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The Use of DHEA in Women With Premature Ovarian Failure

This study has been withdrawn prior to enrollment.
(very poor patient recruitement)
Sponsor:
Information provided by (Responsible Party):
Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier:
NCT01129947
First received: May 23, 2010
Last updated: January 26, 2013
Last verified: January 2013
History of Changes
  Purpose

DHEA supplementation has been used in women with infertility and diminished ovarian reserve. There is a small report in 5 women with POF that benefited from the use of DHEA over several months. The investigators aim to evaluate further the use of DHEA in women with Premature ovarian failure (POF).


Condition Intervention Phase
Premature Ovarian Failure
 Drug: DHEA
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of DHEA in Women With Premature Ovarian Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Center for Reproductive Medicine:

Primary Outcome Measures:
  • The Use of DHEA in Women With Premature Ovarian Failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The following outcomes will be evaluated: FSH, AMH, estradiol, ovarian volume, antral follicle count, pregnancy in women seeking to conceive


Enrollment: 0
Study Start Date: May 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHEA Drug: DHEA
DHEA 25 mg tid

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women with POF

Exclusion Criteria:

  • women without ovaries
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129947

Locations
United States, Virginia
Virginia Center for Reproductive Medicine
Reston, Virginia, United States, 20190
Sponsors and Collaborators
Virginia Center for Reproductive Medicine
  More Information

Publications:

Responsible Party: Fady I. Sharara, M.D, Medical Director, Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT01129947     History of Changes
Other Study ID Numbers: VCRM4
Study First Received: May 23, 2010
Last Updated: January 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Menopause, Premature
Primary Ovarian Insufficiency
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
 Endocrine System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013