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Completed

NCT Number: NCT00391417

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

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.

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

estradiol gel

Drug

Primary outcomes

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

  2. Mean change from baseline in daily hot flush severity.

  3. Mean change from baseline in vulvovaginal atrophy symptoms.

Secondary outcomes

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

  2. Percent change from baseline in hot flush severity over time.

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

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

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

  6. Mean change from baseline in physician assessment of vaginal atrophy.

Sponsors and collaborators

Lead sponsor

BioSante Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Oct 24, 2006
Registry last updated
Oct 24, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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