Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

E

EndoCeutics

Status and phase

Completed
Phase 3

Conditions

Vaginal Atrophy

Treatments

Drug: DHEA
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01358760
ERC-234

Details and patient eligibility

About

The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Enrollment

450 patients

Sex

Female

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Postmenopausal women (non-hysterectomized or hysterectomized)
  • Women between 40 and 75 years of age
  • Willing to participate in the study and sign an informed consent
  • Women who have self-identified symptom(s) of vaginal atrophy
  • For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study

Exclusion criteria

  • Undiagnosed abnormal genital bleeding
  • Hypertension equal to or above 140/90 mm Hg
  • The administration of any investigational drug within 30 days of screening visit
  • Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening

Trial design

450 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
0.25% DHEA
Experimental group
Treatment:
Drug: DHEA
0.5% DHEA
Experimental group
Treatment:
Drug: DHEA

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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