Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms

Hot Flashes Clinical Trial

Official title:

Phase III, Multicenter, Double-Blind Study of the Safety and Efficacy of Bio-E-Gel (Topical Estradiol Gel) Versus Placebo for Treatment of Vasomotor Symptoms and Vulvovaginal Atrophy in Postmenopausal Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391417
• Other study ID #: EST005
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2006
• Last updated: October 20, 2006
• Start date: September 2003
• Est. completion date: April 2005

Study information

• Verified date: October 2006
• Source: BioSante Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of a topical estradiol gel for the treatment of hot flushes in postmenopausal women.

Description:

Estrogens are a group of hormones that play an important role in normal sexual and reproductive development in women. Estrogens serve many functions in the body. They stimulate oocyte maturation and endometrial growth, decrease bone resorption, initiate the development of secondary sex characteristics, maintain reproductive organs and glands, and affect the activity of the central nervous system. At menopause, the decrease in estrogen concentrations is often accompanied by vascular instability (hot flushes and night sweats), a rise in the incidence of heart disease, and an increasing rate of bone loss. Estrogen is available as an oral drug, a transdermal patch, or as a gel or lotion. Transdermal estrogen is preferable as compared to oral, since it avoids the first-pass metabolism in the liver. Since release of the WHI findings, current treatment recommendations are for the lowest effective dose for the shortest period of time to treat postmenopausal symptoms.

Comparison: Three doses of a transdermal estradiol gel as compared to placebo for the treatment of vasomotor and vulvovaginal atrophy symptoms in postmenopausal women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal women

• serum estradiol level less than or equal to 20 pg per mL

• serum FSH greater than 40 mIU per mL

Exclusion Criteria:

• Pathological cancer findings on screening

• abnormal endometrium

• serious hepatic, renal or cardiac disease

Study Design

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

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• estradiol gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioSante Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in number of daily moderate to severe hot flushes.
Primary	Mean change from baseline in daily hot flush severity.
Primary	Mean change from baseline in vulvovaginal atrophy symptoms.
Secondary	Percent change from baseline in daily moderate to severe hot flush rates over time.
Secondary	Percent change from baseline in hot flush severity over time.
Secondary	Proportion of subjects with fifty to one hundred percent reductions in daily moderate to severe hot flushes.
Secondary	Proportion of subjects with fifty to one hundred percent reductions in hot flush severity
Secondary	Mean change from baseline in subject vaginal health self assessment over time.
Secondary	Mean change from baseline in physician assessment of vaginal atrophy.