Phase 3
Completed N=695
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
Atrophy
Source: ClinicalTrials.gov NCT02770365 ↗
Enrolled (actual)
695
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Subjects Identified as Responders — 36.8; 32.0; 0.8 percentage of responders
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Identified as Responders |
36.8; 32.0; 0.8 | — |
| SECONDARY Most Bothersome Symptom |
116; 123 | 0.05 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02770365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.