Clinical Trials Logo
  1. Home
  2. Menopause
  3. NCT00196378
  4. Details
NCT00196378 Clinical Trial

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

Menopause Clinical Trial

Official title:
A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00196378
Other study ID # DR-ENJ-301
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated August 30, 2013
Start date November 2004
Est. completion date February 2006

Study information
Verified date January 2010
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- Naturally or surgically postmenopausal

- 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 of endometrial hyperplasia

- Recent history of vaginal bleeding of unknown cause

- Recent history or diagnosis of endometriosis

- Any contraindication to estrogen therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Synthetic Conjugated estrogens, B
1 (0.3mg) tablet daily
Other:
• Placebo
1 tablet daily

Locations
Country Name City State
United States Duramed Investigational Site Alpharetta Georgia
United States Duramed Investigational Site Baton rouge Louisiana
United States Duramed Investigational Site Billings Montana
United States Duramed Investigational Site Boise Idaho
United States Duramed Investigational Site Carmichael California
United States Duramed Investigational Site Clarksville Tennessee
United States Duramed Investigational Site Cleveland Ohio
United States Duramed Investigational Site Colorado Springs Colorado
United States Duramed Investigational Site Columbia South Carolina
United States Duramed Investigational Site Columbus Ohio
United States Duramed Investigational Site Denver Colorado
United States Duramed Investigational Site Evansville Indiana
United States Duramed Investigational Site Fort Worth Texas
United States Duramed Investigational Site Gainesville Florida
United States Duramed Investigational Site Huntsville Alabama
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 Laurel Maryland
United States Duramed Investigational Site Mayfield Heights Ohio
United States Duramed Investigational Site Medford Oregon
United States Duramed Investigational Site Memphis Tennessee
United States Duramed Investigational Site Miami Florida
United States Duramed Investigational Site Miami Florida
United States Duramed Investigational Site Newport News Virginia
United States Duramed Investigational Site Norfolk Virginia
United States Duramed Investigational Site Oklahoma City Oklahoma
United States Duramed Investigational Site Pittsburgh Pennsylvania
United States Duramed Investigational Site San antonio Texas
United States Duramed Investigational Site San diego California
United States Duramed Investigational Site San diego California
United States Duramed Investigational Site Sarasota Florida
United States Duramed Investigational Site Spokane Washington
United States Duramed Investigational Site Sugarland Texas
United States Duramed Investigational Site Tacoma Washington
United States Duramed Investigational Site Tucson Arizona
United States Duramed Investigational Site Venice Florida
United States Duramed Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in the symptom identified by the patient to be most bothersome Randomization to Week 12 No
Primary Mean change in vaginal pH Randomization to Week 12 No
Primary Mean change in maturation index Randomization to Week 12 No
Secondary Safety and tolerability of Enjuvia Duration of study Yes
See also
  Status Clinical Trial Phase
Completed NCT04553029 - A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
Completed NCT03672513 - Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04210583 - RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Completed NCT05617287 - An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause N/A
Recruiting NCT05180266 - Therapeutic Touch and Music in The Menopausal Period N/A
Recruiting NCT04043520 - Bioenergetic Effects of Aging and Menopause (BEAM) Phase 4
Completed NCT03663075 - Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women N/A
Completed NCT03363997 - Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days Phase 1
Not yet recruiting NCT04724135 - Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
Not yet recruiting NCT04728126 - Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
Completed NCT02274571 - Raising Insulin Sensitivity in Post Menopause Early Phase 1
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT02253173 - Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Recruiting NCT01488903 - A Cohort Research of Genetic Susceptibility for Common Obesity in Women N/A
Terminated NCT01633814 - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women N/A
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A