Clinical trial NCT00196378: A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Keywords: vaginal atrophy
vaginal dryness
vaginal itching
vaginal pain
dyspareunia
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in the symptom identified by the patient to be most bothersome
timeFrame: Randomization to Week 12
measure: Mean change in vaginal pH
timeFrame: Randomization to Week 12
measure: Mean change in maturation index
timeFrame: Randomization to Week 12
Secondary outcomes:
measure: Safety and tolerability of Enjuvia
timeFrame: Duration of study
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Carmichael
country: United States
facility: Duramed Investigational Site
state: California
city: San diego
country: United States
facility: Duramed Investigational Site
state: California
city: San diego
country: United States
facility: Duramed Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Denver
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Gainesville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Miami
country: United States
facility: Duramed Investigational Site
state: Florida
city: Miami
country: United States
facility: Duramed Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Duramed Investigational Site
state: Florida
city: Venice
country: United States
facility: Duramed Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Boise
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Evansville
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Baton rouge
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Laurel
country: United States
facility: Duramed Investigational Site
state: Maryland
city: Billings
country: United States
facility: Duramed Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Winston-Salem
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Duramed Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Clarksville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: Duramed Investigational Site
state: Texas
city: San antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Sugarland
country: United States
facility: Duramed Investigational Site
state: Texas
city: Newport News
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Duramed Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Duramed Investigational Site
state: Washington
Study officials:
affiliation: Duramed Research, Inc.
name: Duraemd Protocol Chair
role: STUDY_CHAIR
References:
citation: Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril. 2008 Oct;90(4):1132-8. doi: 10.1016/j.fertnstert.2007.07.1359. Epub 2007 Dec 3.