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

B

BioSante Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Hot Flashes

Treatments

Drug: estradiol gel

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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