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

Completed · Phase 3 · Has a placebo group

Conditions studied: Menopause

In brief

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.

Key facts

Study ID

NCT00361569

Run by

Duramed Research

People needed

622

Starts

2006-08-01

Expected to finish

2007-09-01

Last updated by the study team

2015-04-20

Who can join

Age: 30 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Duramed Investigational Site — Mobile, Alabama, United States
• Duramed Investigational Site — Montgomery, Alabama, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Tucson, Arizona, United States
• Duramed Investigational Site — Carmichael, California, United States
• Duramed Investigational Site — Fresno, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Ramon, California, United States
• Duramed Investigational Site — Colorado Springs, Colorado, United States
• Duramed Investigational Site — Pueblo, Colorado, United States
• Duramed Investigational Site — New London, Connecticut, United States
• Duramed Investigational Site — Clearwater, Florida, United States
• Duramed Investigational Site — Clearwater, Florida, United States
• Duramed Investigational Site — Gainesville, Florida, United States
• Duramed Investigational Site — Jacksonville, Florida, United States
• Duramed Investigational Site — Leesburg, Florida, United States
• Duramed Investigational Site — Miami, Florida, United States
• Duramed Investigational Site — Pinellas Park, Florida, United States
• Duramed Investigational Site — Stuart, Florida, United States
• Duramed Investigational Site — Tampa, Florida, United States
• Duramed Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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