A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

Phase 3

Completed

• Conditions: Menopause
• Interventions: Drug: DR-2041b; Other: Placebo; Drug: DR-2041a

• Registration Number: NCT00361569
• Lead Sponsor: Duramed Research

Brief Summary

This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Detailed Description

The study will include a screening period up to 4 weeks and a 12- week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-03
• Study First Submitted QC: 2006-08-04
• Study First Posted: 2006-08-08
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Results First Submitted: 2008-12-22
• Results First Submitted QC: 2009-03-12
• Results First Posted: 2009-04-14
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 622

Inclusion Criteria

• Naturally or surgically menopausal
• Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)

Exclusion Criteria

• Known sensitivity or contraindication to estrogens or progestins
• History or current diagnosis endometrial hyperplasia
• Recent history of vaginal bleeding of unknown cause
• Recent history or diagnosis of endometriosis
• Any contraindication to estrogen therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	DR-2041b	-
3	Placebo	-
4	Placebo	-
1	DR-2041a	-

Primary Outcome Measures

Name	Time	Method
Mean Change in Vaginal pH	Baseline to Week 12	Change= Week 12 vaginal pH - Baseline vaginal pH
Mean Change in the Symptom Identified by the Patient to be Most Bothersome	Baseline to Week 12	Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.
Mean Change in Maturation Index	Baseline to Week 12	Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells \* 0) + (% Intermediate Cells \* 0.5) + (% Superficial Cells \* 1.0)

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)	Up to Week 12	Any adverse event reported from the beginning of the 28-day screening through the subject's last report.

Trial Locations

Locations (1)

Duramed Investigational Site; 🇺🇸 Tacoma, Washington, United States