Intrarosa Prasterone 6.5 mg Insert, 28-count — NDC 72495-401-28 (Billing 72495-0401-28)
This is a package of 28 inserts of Intrarosa Prasterone 6.5 mg Insert from Millicent US, Inc., marketed since Nov 2020 and currently FDA-listed; retail pharmacies pay about $10.98 per insert (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 72495-401-28 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72495 labeler · 401 product · 28 package
- Package marketed since
- Nov 1, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 28 EA per package
- Barcode (UPC-A, from the NDC)
- 3 7249540128 1
- Medicaid fills, this package
- 2,797 prescriptions in the last four reported quarters
- FDA record last changed
- Aug 13, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 076858
- GCN: 42668
- HICL (First Databank): 012203
- AHFS class code: 68:04.00.00
- RxCUI (RxNorm): 1927688
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Androstan derivatives class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Vaginal prasterone is used to treat changes in and around the vagina due to menopause ("change of life," the end of monthly menstrual periods) that can cause painful sexual intercourse. Prasterone is in a class of medications called steroids. It works by replacing hormones that are normally produced in the body.
Read the full MedlinePlus article ↗- Intrarosa is used to treat moderate to severe pain during sex that's caused by vaginal and vulvar tissue changes that happen after menopause. Those changes — thinning, drying, and...
- It's pretty straightforward. You insert one vaginal insert once a day at bedtime, using the applicator that comes in the package. Bedtime is recommended so you can stay lying down...
- How do I use Intrarosa — is it complicated?
- The most common side effect is vaginal discharge — it was reported in a small percentage of women in clinical trials, so it's something to be aware of but not a cause for alarm in...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Prasterone (prescription drug) — tap one for details:
Prasterone (prescription drug) may be associated with lower levels of 5 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $10.982 | $307.51 / 28 insert |
| Medicaid paysCMS SDUD · 12 mo | $10.52 | $294.45 / 28 insert |
| Medicare drug plans payPart D · Q2 2026 | $11.01 | $308.34 / 28 insert |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72495-0401-28 You're viewing this Main listing | 1 BOX in 1 BOX / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK | 2020-11-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Intrarosa 6.5 mgthis 72495-0401-28 | Millicent | 28 inserts | $10.982 | — | Availability likely | — |
| Intrarosa 6.5 mg 72495-0501-14 | Millicent | 14 inserts | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8957054 ↗ | Method of use | U-1922 | Jan 8, 2030 |
| US 8268806 ↗ | Drug product | — | Mar 19, 2031 |
| US 8629129 ↗ | Drug product | — | Aug 7, 2028 |
Is there a generic version of INTRAROSA 6.5 MG VAG INSERT?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Prasterone Vaginal inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII XDD37N2GPR
A fat derived from coconut oil that has been chemically treated to make it more stable. It works as a binder and lubricant to help hold the medicine together and improve how it flows during manufacturing.
1 inactive ingredient listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Millicent US, Inc. labeler code 72495
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator. One vaginal insert, once daily at bedtime. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Vaginal insert: 6.5 mg of prasterone, smooth, white to off-white solid fat bullet-shaped, measuring 28 mm in length, 9 mm in width at its wider end, and weighing 1.2 gram. Vaginal Insert: 6.5 mg of prasterone. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA. Undiagnosed abnormal genital bleeding. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Current or Past History of Breast Cancer. ( 5.1 )
5.1Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.
5.1Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥ 2 percent was vaginal discharge. ( 6.1 ) In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥ 2 percent were vaginal discharge and abnormal Pap smear. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Millicent U.S.
Inc at 1-877-810-2101 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In four (4) placebo-controlled, 12-week clinical trials [91% - White Caucasian non-Hispanic women, 7% - Black or African American women, and 2% - "Other" women, average age 58.8 years of age (range 40 to 80 years of age)], vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the INTRAROSA treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group.
There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the INTRAROSA treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment group. In a 52-week non-comparative clinical trial [92% - White Caucasian non-Hispanic women, 6% - Black or African American women, and 2% - "Other" women, average age 57.9 years of age (range 43 to 75 years of age)], vaginal discharge and abnormal Pap smear at 52 weeks were the most frequently reported treatment-emergent adverse reaction in women receiving INTRAROSA with an incidence of ≥ 2 percent.
There were 74 cases of vaginal discharge (14.2 percent) and 11 cases of abnormal Pap smear (2.1 percent) in 521 participating postmenopausal women. The eleven (11) cases of abnormal Pap smear at 52 weeks include one (1) case of low-grade squamous intraepithelial lesion (LSIL), and ten (10) cases of atypical cells of undetermined significance (ASCUS).
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In four (4) placebo-controlled, 12-week clinical trials [91% - White Caucasian non-Hispanic women, 7% - Black or African American women, and 2% - "Other" women, average age 58.8 years of age (range 40 to 80 years of age)], vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the INTRAROSA treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group.
There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the INTRAROSA treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment group. In a 52-week non-comparative clinical trial [92% - White Caucasian non-Hispanic women, 6% - Black or African American women, and 2% - "Other" women, average age 57.9 years of age (range 43 to 75 years of age)], vaginal discharge and abnormal Pap smear at 52 weeks were the most frequently reported treatment-emergent adverse reaction in women receiving INTRAROSA with an incidence of ≥ 2 percent.
There were 74 cases of vaginal discharge (14.2 percent) and 11 cases of abnormal Pap smear (2.1 percent) in 521 participating postmenopausal women. The eleven (11) cases of abnormal Pap smear at 52 weeks include one (1) case of low-grade squamous intraepithelial lesion (LSIL), and ten (10) cases of atypical cells of undetermined significance (ASCUS).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary INTRAROSA is indicated only in postmenopausal women. There are no data with INTRAROSA use in pregnant women regarding any drug-associated risks. Animal reproduction studies have not been conducted with prasterone.
8.2Lactation Risk Summary INTRAROSA is indicated only in postmenopausal women. There is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production.
8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.
8.5Geriatric Use Of the 1522 prasterone-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinical trial, 19 and 11 percent, respectively, were 65 years of age or older.
8.6Renal Impairment The effect of renal impairment on the pharmacokinetics of prasterone has not been studied.
8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of prasterone has not been studied.
8.1Pregnancy Risk Summary INTRAROSA is indicated only in postmenopausal women. There are no data with INTRAROSA use in pregnant women regarding any drug-associated risks. Animal reproduction studies have not been conducted with prasterone.
8.2Lactation Risk Summary INTRAROSA is indicated only in postmenopausal women. There is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production.
8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients.
8.5Geriatric Use Of the 1522 prasterone-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinical trial, 19 and 11 percent, respectively, were 65 years of age or older.
8.6Renal Impairment The effect of renal impairment on the pharmacokinetics of prasterone has not been studied.
8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of prasterone has not been studied.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of INTRAROSA in postmenopausal women with vulvar and vaginal atrophy is not fully established.
12.3Pharmacokinetics In a study conducted in postmenopausal women, administration of the INTRAROSA vaginal insert once daily for 7 days resulted in a mean prasterone C max and area under the curve from 0 to 24 hours (AUC 0-24 ) at Day 7 of 4.4 ng/mL and 56.2 ng·h/mL, respectively, which were significantly higher than those in the group treated with placebo ( Table 1 ). The C max and AUC 0-24 of the metabolites testosterone and estradiol were also slightly higher in women treated with the INTRAROSA vaginal insert compared to those receiving placebo.
Table 1. C max and AUC 0-24 of Prasterone, Testosterone, and Estradiol on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± SD). 1 : N=8 Placebo (N=9) INTRAROSA (N=10) Prasterone C max (ng/mL) 1.60 (±0.95) 4.42 (±1.49) AUC 0-24 (ng·h/mL) 24.82 (±14.31) 56.17 (±28.27) Testosterone C max (ng/mL) 0.12 (±0.04) 1 0.15 (±0.05) AUC 0-24 (ng·h/mL) 2.58 (±0.94) 1 2.79 (±0.94) Estradiol C max (pg/mL) 3.33 (±1.31) 5.04 (±2.68) AUC 0-24 (pg·h/mL) 66.49 (±20.70) 96.93 (±52.06) Figure 1.
Serum Concentrations of Prasterone (A), Testosterone (B), and Estradiol (C) Measured Over a 24h Period on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± S.D.). In two primary efficacy trials, daily administration of INTRAROSA vaginal insert for 12 weeks increased mean serum C trough of prasterone and its metabolites testosterone and estradiol by 47%, 21% and 19% from baseline, respectively. This comparison based on C trough may underestimate the magnitude of increase in prasterone and metabolites’ exposure because it does not take into account the overall concentration-time profile following administration of INTRAROSA.
Metabolism Exogenous prasterone is metabolized in the same manner as endogenous prasterone. Human steroidogenic enzymes such as hydroxysteroid dehydrogenases, 5α-reductases and aromatases transform prasterone into androgens and estrogens. Figure 1
12.1Mechanism of Action Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of INTRAROSA in postmenopausal women with vulvar and vaginal atrophy is not fully established.
12.3Pharmacokinetics In a study conducted in postmenopausal women, administration of the INTRAROSA vaginal insert once daily for 7 days resulted in a mean prasterone C max and area under the curve from 0 to 24 hours (AUC 0-24 ) at Day 7 of 4.4 ng/mL and 56.2 ng·h/mL, respectively, which were significantly higher than those in the group treated with placebo ( Table 1 ). The C max and AUC 0-24 of the metabolites testosterone and estradiol were also slightly higher in women treated with the INTRAROSA vaginal insert compared to those receiving placebo.
Table 1. C max and AUC 0-24 of Prasterone, Testosterone, and Estradiol on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± SD). 1 : N=8 Placebo (N=9) INTRAROSA (N=10) Prasterone C max (ng/mL) 1.60 (±0.95) 4.42 (±1.49) AUC 0-24 (ng·h/mL) 24.82 (±14.31) 56.17 (±28.27) Testosterone C max (ng/mL) 0.12 (±0.04) 1 0.15 (±0.05) AUC 0-24 (ng·h/mL) 2.58 (±0.94) 1 2.79 (±0.94) Estradiol C max (pg/mL) 3.33 (±1.31) 5.04 (±2.68) AUC 0-24 (pg·h/mL) 66.49 (±20.70) 96.93 (±52.06) Figure 1.
Serum Concentrations of Prasterone (A), Testosterone (B), and Estradiol (C) Measured Over a 24h Period on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± S.D.). In two primary efficacy trials, daily administration of INTRAROSA vaginal insert for 12 weeks increased mean serum C trough of prasterone and its metabolites testosterone and estradiol by 47%, 21% and 19% from baseline, respectively. This comparison based on C trough may underestimate the mag… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied INTRAROSA is supplied as white to off-white 1.3 mL solid fat bullet-shaped, smooth vaginal inserts (containing 6.5 mg of prasterone). INTRAROSA is available in small boxes of 4 blister packs containing 7 vaginal inserts (28 vaginal inserts per box). The small box (containing the vaginal inserts) is supplied inside a larger box containing 28 applicators (NDC 72495-401-28).
16.2Storage and Handling Store at 41°F to 86°F (5°C to 30°C). Can be stored at room temperature or in the refrigerator.
16.1How Supplied INTRAROSA is supplied as white to off-white 1.3 mL solid fat bullet-shaped, smooth vaginal inserts (containing 6.5 mg of prasterone). INTRAROSA is available in small boxes of 4 blister packs containing 7 vaginal inserts (28 vaginal inserts per box). The small box (containing the vaginal inserts) is supplied inside a larger box containing 28 applicators (NDC 72495-401-28).
📦 Storage and Handling ▾
16.2Storage and Handling Store at 41°F to 86°F (5°C to 30°C). Can be stored at room temperature or in the refrigerator.
📋 Description ▾
11 DESCRIPTION INTRAROSA (prasterone) vaginal insert is a vaginally administered steroid. Prasterone is identified chemically as 3β-hydroxyandrost-5-en-17-one. It has the empirical formula C 19 H 28 O 2 with a molecular weight of 288.424 g/mol.
Prasterone is a white to off-white crystalline powder insoluble in water and soluble in sodium lauryl sulfate (SLS). The structural formula is: Each INTRAROSA (prasterone) vaginal insert contains 6.5 mg of prasterone in 1.3 ml of off-white hard fat (Witepsol). Prasterone
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read FDA-approved patient labeling (Patient Information and Instructions for Use). Vaginal Discharge Inform postmenopausal women that vaginal discharge may occur with INTRAROSA [see Adverse Reactions ( 6.1 )]. Abnormal Pap Smear Findings Inform postmenopausal women that abnormal Pap smear findings may occur with INTRAROSA [see Adverse Reactions ( 6.1 )].
Manufactured for: Cosette Pharmaceuticals, Inc., Bridgewater, NJ 08807, USA Distributed by: Millicent U.S. Inc, East Hanover, NJ 07936
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The effectiveness of INTRAROSA on moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause was examined in two primary 12-week placebo-controlled efficacy trials. The first clinical trial (Trial 1) was a 12-week randomized, double-blind and placebo-controlled trial that enrolled 255 generally healthy postmenopausal women between 40 to 75 years of age (mean 58.6 years) who, at baseline, identified moderate to severe dyspareunia as their most bothersome symptom of vulvar and vaginal atrophy.
In addition to moderate to severe dyspareunia, women had ≤ 5% superficial cells on vaginal smear and a vaginal pH > 5. Women were randomized in a 1:1:1 ratio between three treatment groups who received daily INTRAROSA (n=87), one active comparator vaginal insert (n=87), or placebo (n=81). All women were assessed for improvement from Baseline to Week 12 for four co-primary efficacy endpoints: most bothersome moderate to severe symptom of dyspareunia, the percentage of vaginal superficial cells, the percentage of parabasal cells, and vaginal pH.
The second clinical trial (Trial 2) was a 12-week randomized, double-blind and placebo-controlled trial that enrolled 558 generally healthy postmenopausal women between 40 to 80 years of age (mean 59.5 years) who, at baseline, had identified moderate to severe dyspareunia as their most bothersome symptom of vulvar and vaginal atrophy. In addition to dyspareunia, women had ≤ 5% superficial cells on vaginal smear and a vaginal pH > 5. Women were randomized in a 2:1 ratio to receive once daily vaginal insert containing 6.5 mg INTRAROSA (n=376) or placebo (n=182).
The primary endpoints and study conduct were the same or similar to those in Trial 1. The primary efficacy results obtained in the Intent-to-Treat (ITT) population in Trial 1 are shown in Table 2 . Table 2: Efficacy Summary in Primary 12-Week Trial 1: ITT Population (LOCF) 1 Difference from placebo =INTRAROSA (Week 12 mean – Baseline mean) – Placebo (Week 12 mean – Baseline mean).
2 ANCOVA: Treatment as the main factor and Baseline value as the covariate. Placebo N = 77 INTRAROSA N = 81 Dyspareunia Baseline Mean Severity Week 12 Mean Severity Mean Change in Severity (SD) Difference from Placebo 1 p-value 2 2.58 1.71 -0.87 (0.95) - - 2.63 1.36 -1.27 (0.99) -0.40 0.0132 % Superficial Cells Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 0.73 1.64 0.91 (2.69) - - 0.68 6.30 5.62 (5.49) 4.71 <0.0001 % Parabasal Cells Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 68.48 66.86 -1.62 (28.22) - - 65.05 17.65 -47.40 (42.50) -45.77 <0.0001 Vaginal pH Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 6.51 6.31 -0.21 (0.69) - - 6.47 5.43 -1.04 (1.00) -0.83 <0.0001 The primary efficacy results obtained in the Intent-to-Treat (ITT) population in Trial 2 are shown in Table 3 .
Table 3: Efficacy Summary in Primary 12-Week Trial 2: ITT Population (LOCF) 1 Difference from placebo =INTRAROSA (Week 12 mean – Baseline mean) – Placebo (Week 12 mean – Baseline mean). 2 ANCOVA: Treatment as the main factor and Baseline value as the covariate. Placebo N = 157 INTRAROSA N = 325 Dyspareunia Baseline Mean Severity Week 12 Mean Severity Mean Change in Severity (SD) Difference from Placebo 1 p-value 2 2.56 1.50 -1.06 (1.02) - - 2.54 1.13 -1.42 (1.00) -0.35 0.0002 % Superficial Cells Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 1.04 2.78 1.75 (3.33) - - 1.02 11.22 10.20 (10.35) 8.46 <0.0001 % Parabasal Cells Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 51.66 39.68 -11.98 (29.58) - - 54.25 12.74 -41.51 (36.26) -29.53 <0.0001 Vaginal pH Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 6.32 6.05 -0.27 (0.74) - - 6.34 5.39 -0.94 (0.94) -0.67 <0.0001
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to evaluate carcinogenic potential have not been conducted with prasterone. Two metabolites of prasterone, testosterone and estradiol, are carcinogenic in animals. Mutagenesis Prasterone was not genotoxic in the in vitro bacterial mutagenesis assay (Ames test), the in vitro chromosomal aberrations assay with human peripheral blood lymphocytes, and in vivo in the mouse bone marrow micronucleus assay.
Fertility Fertility studies were not conducted with prasterone.
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to evaluate carcinogenic potential have not been conducted with prasterone. Two metabolites of prasterone, testosterone and estradiol, are carcinogenic in animals. Mutagenesis Prasterone was not genotoxic in the in vitro bacterial mutagenesis assay (Ames test), the in vitro chromosomal aberrations assay with human peripheral blood lymphocytes, and in vivo in the mouse bone marrow micronucleus assay.
Fertility Fertility studies were not conducted with prasterone.
📄 Patient Package Insert ▾
Patient Information INTRAROSA ® (in trah ROE sah) (prasterone) vaginal inserts What is INTRAROSA vaginal inserts? INTRAROSA vaginal inserts are a prescription medicine used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause. It is not known if INTRAROSA vaginal inserts are safe and effective in children.
Do not use INTRAROSA vaginal inserts if you have vaginal bleeding that has not been checked by your healthcare provider. Before using INTRAROSA vaginal inserts, tell your healthcare provider about all of your medical conditions, including if you: • have, have had, or think you may have had breast cancer. Prasterone, an ingredient in INTRAROSA vaginal inserts, is changed in your body to estrogen.
Estrogen medicines are not for use in women who have, have had, or think they may have had breast cancer. • are pregnant or plan to become pregnant. INTRAROSA is only for use in women who are past menopause. It is not known if INTRAROSA vaginal inserts will harm your unborn baby. • are breastfeeding or plan to breastfeed.
INTRAROSA vaginal inserts are only for use in women who are past menopause. It is not known if INTRAROSA passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use INTRAROSA vaginal inserts? • See the Instructions for Use at the end of this Patient Information for detailed instructions about the right way to use INTRAROSA vaginal inserts. • Use INTRAROSA vaginal inserts exactly how your healthcare provider tells you to use it. • Place 1 INTRAROSA vaginal insert in your vagina one time each day at bedtime, using the applicator that comes with INTRAROSA vaginal inserts. What are the possible side effects of INTRAROSA vaginal inserts? The most common side effects of INTRAROSA vaginal inserts are vaginal discharge and changes on Pap smear.
These are not all of the possible side effects of INTRAROSA vaginal inserts. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store INTRAROSA vaginal inserts? • Store INTRAROSA vaginal inserts between 41°F to 86°F (5°C to 30°C). • INTRAROSA vaginal inserts can be stored at room temperature or in the refrigerator. Keep INTRAROSA vaginal inserts and all medicines out of the reach of children. General Information about the safe and effective use of INTRAROSA vaginal inserts.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INTRAROSA vaginal inserts for a condition for which it was not prescribed. Do not give INTRAROSA vaginal inserts to other people, even if they have the same symptoms that you have.
It may harm them. You can ask your pharmacist or healthcare provider for information about INTRAROSA vaginal inserts that is written for health professionals. What are the ingredients in INTRAROSA vaginal inserts?
Active ingredient: prasterone Inactive ingredient: off-white hard fat (Witepsol) For more information, go to: www.intrarosa.com or call Millicent U.S. Inc at 1-877-810-2101
📖 Instructions for Use ▾
Instructions for Use INTRAROSA (in trah ROE sah) (prasterone) vaginal inserts How should I use INTRAROSA vaginal inserts? • INTRAROSA is a vaginal insert that you place in your vagina with an applicator that comes with INTRAROSA vaginal inserts. • Use 1 INTRAROSA vaginal insert, one time each day at bedtime. • Each applicator is for one time use only. • Empty your bladder and wash your hands before handling the vaginal insert and applicator. • Tear off 1 vaginal insert along the perforations from the 7-vaginal insert strip.
STEP 1 1a. Remove 1 applicator from the package. 1b.
Pull back on the plunger until it stops to activate the applicator. The applicator must be activated before use. Place the applicator on a clean surface.
STEP 5 Select the position for insertion of the vaginal insert that is most comfortable for you. 5a. Lying position STEP 2 Slowly pull the plastic tabs on the vaginal insert away from each other while keeping the vaginal insert still between your fingers.
Carefully remove the vaginal insert from the plastic wrap. If a vaginal insert falls on an unsanitary surface, replace it with a new one. 5b.
Standing position STEP 3 Place the flat end of the vaginal insert into the open end of the activated applicator as shown. You are now ready to insert the vaginal insert into your vagina. STEP 6 Gently slide the vaginal insert end of the applicator into your vagina as far as it will comfortably go.
Do not use force. STEP 4 Hold the applicator between your thumb and middle finger. Leave your index (pointer) finger free to press the applicator plunger after the applicator is inserted into your vagina.
STEP 7 Press the applicator plunger with your index (pointer) finger to release the vaginal insert. Remove the applicator and throw it away after use. For more information, go to: www.intrarosa.com or call Millicent U.S.
Inc at 1-877-810-2101. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
INTRAROSA ® is a registered trademark of Myriel Pharmaceuticals, LLC, a subsidiary of Cosette Pharmaceuticals, Inc. Manufactured for: Cosette Pharmaceuticals, Inc., Bridgewater, NJ 08807, USA © 2024 Cosette Pharmaceuticals, Inc. Distributed by: Millicent U.S.
Inc, East Hanover, NJ 07936 © 2020 Millicent Pharma Limited Issued January 2026 Step 1 Step 5a Step 2 Step 5b Step 3 Step 6 Step 4 Step 7 Cosette Pharmaceuticals Millicent Pharma
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - NDC: 72495-401-28 - Small Box (Inserts) Small Box
PRINCIPAL DISPLAY PANEL - NDC: 72495-401-28 - Outmost Large Box (Inserts plus Applicators) Outer Box
PRINCIPAL DISPLAY PANEL - NDC: 72495-501-14 - Professional Sample Small Box (Inserts) Sample Small Box
PRINCIPAL DISPLAY PANEL - NDC: 72495-501-14 - Professional Sample Outmost Large Box (Inserts plus Applicators) Sample Outer Box