Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy (NCT02770365) | Clinical Trial Compass
CompletedPhase 3
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
United States695 participantsStarted 2016-05
Plain-language summary
To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.
Who can participate
Age range
30 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 and otherwise healthy, 30 - 75 years of age.
* ≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.
* vaginal pH \> 5.0 at Visit 1/Screening
* Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome
* For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm.
* Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization
Exclusion Criteria:
* Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.
* Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer.
* Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more
* History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients.
* Known or suspected estrogen-dependent neoplasia.
* Has deep vein thrombosis, pulmonary embolism or history of these conditions.
• Subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions.
* Known acute or chronic hepatic disease or dysfunction
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.