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

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ClinicalTrials.gov Identifier: NCT00391417
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : October 24, 2006
Sponsor:
Information provided by:
BioSante Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: estradiol gel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2003
Study Completion Date : April 2005





Primary Outcome Measures :
  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 Outcome Measures :
  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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00391417    
Other Study ID Numbers: EST005
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: October 24, 2006
Last Verified: October 2006
Keywords provided by BioSante Pharmaceuticals:
hot flush
hot flash
estrogen
vaginal atrophy
Additional relevant MeSH terms:
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Hot Flashes
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs