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

Primary Purpose

Hot Flashes

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

estradiol gel

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring hot flush, hot flash, estrogen, vaginal atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Mean change from baseline in number of daily moderate to severe hot flushes.

Mean change from baseline in daily hot flush severity.

Mean change from baseline in vulvovaginal atrophy symptoms.

Secondary Outcome Measures

Percent change from baseline in daily moderate to severe hot flush rates over time.

Percent change from baseline in hot flush severity over time.

Proportion of subjects with fifty to one hundred percent reductions in daily moderate to severe hot flushes.

Proportion of subjects with fifty to one hundred percent reductions in hot flush severity

Mean change from baseline in subject vaginal health self assessment over time.

Mean change from baseline in physician assessment of vaginal atrophy.

Full Information

NCT ID

NCT00391417

First Posted

October 20, 2006

Last Updated

October 20, 2006

Sponsor

BioSante Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00391417

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

BioSante Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hot Flashes

Keywords

hot flush, hot flash, estrogen, vaginal atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

431 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

estradiol gel

Primary Outcome Measure Information:

Title

Mean change from baseline in number of daily moderate to severe hot flushes.

Title

Mean change from baseline in daily hot flush severity.

Title

Mean change from baseline in vulvovaginal atrophy symptoms.

Secondary Outcome Measure Information:

Title

Percent change from baseline in daily moderate to severe hot flush rates over time.

Title

Percent change from baseline in hot flush severity over time.

Title

Proportion of subjects with fifty to one hundred percent reductions in daily moderate to severe hot flushes.

Title

Proportion of subjects with fifty to one hundred percent reductions in hot flush severity

Title

Mean change from baseline in subject vaginal health self assessment over time.

Title

Mean change from baseline in physician assessment of vaginal atrophy.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

17329509

Citation

Simon JA, Bouchard C, Waldbaum A, Utian W, Zborowski J, Snabes MC. Low dose of transdermal estradiol gel for treatment of symptomatic postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Mar;109(3):588-96. doi: 10.1097/01.AOG.0000254160.62588.41.

Results Reference

derived

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

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