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

This study has been completed.
Sponsor:
Information provided by:
BioSante Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00391417
First received: October 20, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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 Intervention Phase
Hot Flashes
Drug: estradiol gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by BioSante Pharmaceuticals:

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.

Estimated Enrollment: 431
Study Start Date: September 2003
Estimated Study Completion Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by BioSante Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00391417     History of Changes
Other Study ID Numbers: EST005
Study First Received: October 20, 2006
Last Updated: October 20, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by BioSante Pharmaceuticals:
hot flush
hot flash
estrogen
vaginal atrophy

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on April 17, 2014