A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy

Completed · Phase 3 · Has a placebo group

Conditions studied: Menopause

In brief

This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Key facts

Study ID

NCT00196378

Run by

Duramed Research

People needed

300

Starts

2004-11-01

Expected to finish

2006-02-01

Last updated by the study team

2013-09-02

Who can join

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

You may qualify if…

• Naturally or surgically postmenopausal
• 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 of 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 — Huntsville, Alabama, United States
• Duramed Investigational Site — Tucson, Arizona, United States
• Duramed Investigational Site — Carmichael, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — Colorado Springs, Colorado, United States
• Duramed Investigational Site — Denver, Colorado, United States
• Duramed Investigational Site — Gainesville, Florida, United States
• Duramed Investigational Site — Miami, Florida, United States
• Duramed Investigational Site — Miami, Florida, United States
• Duramed Investigational Site — Sarasota, Florida, United States
• Duramed Investigational Site — Venice, Florida, United States
• Duramed Investigational Site — Alpharetta, Georgia, United States
• Duramed Investigational Site — Boise, Idaho, United States
• Duramed Investigational Site — Evansville, Indiana, United States
• Duramed Investigational Site — Baton Rouge, Louisiana, United States
• Duramed Investigational Site — Laurel, Maryland, United States
• Duramed Investigational Site — Billings, Montana, United States
• Duramed Investigational Site — Las Vegas, Nevada, United States
• Duramed Investigational Site — Las Vegas, Nevada, United States
• Duramed Investigational Site — Las Vegas, Nevada, United States
• Duramed Investigational Site — Winston-Salem, North Carolina, United States
• Duramed Investigational Site — Cleveland, Ohio, United States
• Duramed Investigational Site — Columbus, Ohio, United States
• Duramed Investigational Site — Mayfield Heights, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.