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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01129947
Other study ID # VCRM4
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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