The Use of DHEA in Women With Premature Ovarian Failure

Premature Ovarian Failure Clinical Trial

Official title:

The Use of DHEA in Women With Premature Ovarian Failure

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01129947
• Other study ID #: VCRM4
• Status: Withdrawn
• Phase: Phase 0
• First received: May 23, 2010
• Last updated: January 26, 2013
• Start date: May 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Virginia Center for Reproductive Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• women with POF

Exclusion Criteria:

• women without ovaries

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Drug:
• DHEA
DHEA 25 mg tid

Locations

Country	Name	City	State
United States	Virginia Center for Reproductive Medicine	Reston	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Center for Reproductive Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Use of DHEA in Women With Premature Ovarian Failure	The following outcomes will be evaluated: FSH, AMH, estradiol, ovarian volume, antral follicle count, pregnancy in women seeking to conceive	3 years	No