Back to resultsThe Use of DHEA in Women With Premature Ovarian Failure
Primary Purpose
Premature Ovarian Failure
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
DHEA
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ovarian Failure
Eligibility Criteria
Inclusion Criteria:
- women with POF
Exclusion Criteria:
- women without ovaries
Sites / Locations
- Virginia Center for Reproductive Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DHEA
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01129947
First Posted
May 23, 2010
Last Updated
January 26, 2013
Sponsor
Virginia Center for Reproductive Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01129947
Brief Title
The Use of DHEA in Women With Premature Ovarian Failure
Official Title
The Use of DHEA in Women With Premature Ovarian Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Why Stopped
very poor patient recruitement
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Center for Reproductive Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DHEA
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DHEA
Intervention Description
DHEA 25 mg tid
Primary Outcome Measure Information:
Title
The Use of DHEA in Women With Premature Ovarian Failure
Description
The following outcomes will be evaluated: FSH, AMH, estradiol, ovarian volume, antral follicle count, pregnancy in women seeking to conceive
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with POF
Exclusion Criteria:
women without ovaries
Facility Information:
Facility Name
Virginia Center for Reproductive Medicine
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19610174
Citation
Mamas L, Mamas E. Dehydroepiandrosterone supplementation in assisted reproduction: rationale and results. Curr Opin Obstet Gynecol. 2009 Aug;21(4):306-8. doi: 10.1097/gco.0b013e32832e0785.
Results Reference
background
Learn more about this trial
The Use of DHEA in Women With Premature Ovarian Failure
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