Phase 3
Completed N=535
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
Atrophic Vaginitis
Source: ClinicalTrials.gov NCT02995694 ↗
Enrolled (actual)
535
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Vaginal Cytology — 29; 19; 0 participants
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vaginal Cytology |
29; 19; 0 | — |
| SECONDARY Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy |
115; 114; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent that meets all criteria of current FDA regulations
- Females age: 30-75 years old inclusive who are postmenopausal.
- Postmenopausal defined as at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. Hysterectomy without oophorectomy if of age that investigator believes would have naturally reached 12 months of spontaneous amenorrhea.
- Baseline evaluation requirements:
- ≤5% superficial cells on vaginal smear cytology
- Vaginal pH > 5.0
- At least one patient self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy (VVA) from the following list that is identified by the subject:
- Vaginal dryness
- Vaginal and/or vulvar irritation/itching
- Dysuria
- Vaginal pain associated with sexual activity*
- Vaginal bleeding associated with sexual activity (absence vs. presence)* *provided that patient is currently sexually active and plans to remain so throughout study.
- Normal breast exam at screening and mammogram completed within 9 months prior to screening in patients >40 years old.
- For women with an intact uterus, an endometrial thickness 150mm Hg and/or diastolic pressure > 90 mm Hg
- Any patient with undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
- Any history of estrogen-dependent neoplasia (e.g., endometrial cancer).
Data sourced from ClinicalTrials.gov (NCT02995694). 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.