CompletedPhase 3

Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women

United States, Canada764 participantsStarted 2014-09

Plain-language summary

This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.

Who can participate

Age range

40 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Postmenopausal female subjects between the ages of 40 and 75 years (at the time of randomization) with at least:
. ≤5% superficial cells on vaginal cytological smear
. Vaginal pH \> 5.0
. Moderate to severe symptom of vaginal pain associated with sexual activity considered the most bothersome vaginal symptom by the subject at screening visit 1A.
. Moderate to severe symptom of vaginal pain associated with sexual activity at screening visit 1B.
. Onset of moderate to severe dyspareunia in the postmenopausal years.
. Subjects should be sexually active (i.e. have sexual activity with vaginal penetration within approximately 1 month of screening visit 1A).
. Subjects should anticipate having sexual activity (with vaginal penetration) during the conduct of the trial.

Exclusion criteria

. Use of the following:
. Oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening visit 1A (can enter washout);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Co-Primary Efficacy Endpoint - Vaginal Superficial Cells

Timeframe: Baseline and 12 Weeks

Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells

Timeframe: Baseline and 12 Weeks

Co-Primary Efficacy Endpoint - Vaginal pH

Timeframe: Baseline and 12 Weeks

Co-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia)

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT02253173

SponsorTherapeuticsMD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10

Results submitted2016-08-08

View on ClinicalTrials.gov More Vulvovaginal Atrophy trials

Who can participate

Age range

40 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Postmenopausal female subjects between the ages of 40 and 75 years (at the time of randomization) with at least:
. ≤5% superficial cells on vaginal cytological smear
. Vaginal pH \> 5.0
. Moderate to severe symptom of vaginal pain associated with sexual activity considered the most bothersome vaginal symptom by the subject at screening visit 1A.
. Moderate to severe symptom of vaginal pain associated with sexual activity at screening visit 1B.
. Onset of moderate to severe dyspareunia in the postmenopausal years.
. Subjects should be sexually active (i.e. have sexual activity with vaginal penetration within approximately 1 month of screening visit 1A).
. Subjects should anticipate having sexual activity (with vaginal penetration) during the conduct of the trial.

Exclusion criteria

. Use of the following:
. Oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening visit 1A (can enter washout);

What they're measuring

Co-Primary Efficacy Endpoint - Vaginal Superficial Cells

Timeframe: Baseline and 12 Weeks

Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells

Timeframe: Baseline and 12 Weeks

Co-Primary Efficacy Endpoint - Vaginal pH

Timeframe: Baseline and 12 Weeks

Co-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia)

Timeframe: Baseline and Week 12