Completed PHASE3 INTERVENTIONAL 4-arm NCT00361569

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

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women

Sponsor: Duramed Research

Conditions Menopause

Interventions DR-2041a DR-2041b Placebo

Updated 8 times since 2017 Last updated: Mar 30, 2015 Started: Aug 31, 2006 Primary completion: Sep 30, 2007 Completion: Sep 30, 2007

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Menopause and is currently completed. Duramed Research leads this study, which shows 8 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

Status Flow

Change History

8 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE3
Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2022 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Jan 2022 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Aug 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Duramed Research

Data source: Teva Branded Pharmaceutical Products R&D, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Allentown, United States , Alpharetta, United States , Atlanta, United States , Augusta, United States , Austin, United States , Baltimore, United States , Carmichael, United States , Charleston, United States , Chicago, United States and 70 more locations