CompletedPhase 3

A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis

535 participantsStarted 2016-03

Plain-language 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.

Who can participate

Age range30 Years – 75 Years

SexFEMALE

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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:
✓. 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 \< 4 mm as determined by vaginal ultrasonography.
✓. Documented PAP smear conducted within previous 12 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol

Exclusion criteria

✕. Females younger than 30 years of age or older than 75 years of age
✕. Patients with a serum FSH level of ≤ 40mIU/ml at screening.
✕. Greater than 5% superficial cells on vaginal cytology.
✕. Vaginal pH ≤ 5
✕. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder (including significant liver/kidney impairment) or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
✕. Patients with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining. Patients with an endometrial thickness equal to or greater than 4mm should be excluded.
✕. Patients with known, suspected or current history of carcinoma of the breast. All patients over the age of 40 must have had a mammogram performed within 9 months of the study start and all patients will have a physical breast exam performed at screening.
✕. Patients with baseline systolic blood pressure of \> 150mm Hg and/or diastolic pressure \> 90 mm Hg

What they're measuring

Vaginal Cytology

Timeframe: Day 8

Trial details

NCT IDNCT02995694

SponsorAlvogen Pine Brook LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2019-05-15

View on ClinicalTrials.gov More Atrophic Vaginitis trials