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Completed

NCT Number: NCT01452373

Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women

The purpose of this Phase III trial is to evaluate the efficacy of oral administration of dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.

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Key information

Conditions

Vasomotor Symptoms Hot Flashes Hot Flushes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

EndoCeutics site # 06, Bathurst, New Brunswick, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Main 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 having many moderate to severe hot flushes.
  • For non-hysterectomized women, willing to have an endometrial biopsy at baseline and end of-study.

Main 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 (simple or complex hyperplasia with or without atypia), cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.

Treatment and study plan

Placebo

Drug

Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.

DHEA and Acolbifene

Drug

DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.

Other names: Prasterone; dehydroepiandrosterone; EM-652.HCl

Primary outcomes

  1. Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.

    Time frame: 12 weeks

  2. Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).

    Time frame: 12 weeks

  2. Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.

    Time frame: 12 weeks

  3. Tolerance to systemic administration of DHEA and acolbifene.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

EndoCeutics Inc.

Industry

Registry information

Official study title

DHEA + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women (Placebo Controlled, Double Blind and Randomized Phase III Study to Evaluate the Effects of 12-Week Treatment With DHEA (Prasterone) and Acolbifene on Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women)

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 14, 2011
Registry last updated
Dec 11, 2013

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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