The Use of DHEA in Women With Premature Ovarian Failure

This study is currently recruiting participants.

Verified May 2010 by Virginia Center for Reproductive Medicine

First Received on May 23, 2010. Last Updated on May 24, 2010 History of Changes

Sponsor:	Virginia Center for Reproductive Medicine
Information provided by:	Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier:	NCT01129947

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:

MedlinePlus related topics: Premature Ovarian Failure

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

Estimated Enrollment:	25
Study Start Date:	May 2010
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2011 (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

Contacts

Contact: Fady I Sharara, M.D

7034377722

fsharara@vcrmed.com

Locations

United States, Virginia
Virginia Center for Reproductive Medicine	Recruiting
Reston, Virginia, United States, 20190
Contact: Fady I Sharara, M.D 703-437-7722 info@vcrmed.com
Principal Investigator: Fady I Sharara, M.D

Sponsors and Collaborators

Virginia Center for Reproductive Medicine

More Information

Publications:

Mamas L, Mamas E. Dehydroepiandrosterone supplementation in assisted reproduction: rationale and results. Curr Opin Obstet Gynecol. 2009 Aug;21(4):306-8. Review.

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:	May 24, 2010
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 23, 2012