The Use of DHEA in Women With Premature Ovarian Failure
This study has been withdrawn prior to enrollment.
(very poor patient recruitement)
Sponsor:
Virginia Center for Reproductive Medicine
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
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 23, 2010 |
| Last Updated Date | January 26, 2013 |
| Start Date ICMJE | May 2010 |
| Primary Completion Date | January 2013 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01129947 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | The Use of DHEA in Women With Premature Ovarian Failure |
| Official Title ICMJE | The Use of DHEA in Women With Premature Ovarian Failure |
| 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). |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 0 |
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Premature Ovarian Failure |
| Intervention ICMJE | Drug: DHEA
DHEA 25 mg tid |
| Study Arm (s) | Experimental: DHEA
Intervention: Drug: DHEA |
| Publications * | Mamas L, Mamas E. Dehydroepiandrosterone supplementation in assisted reproduction: rationale and results. Curr Opin Obstet Gynecol. 2009 Aug;21(4):306-8. Review. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Withdrawn |
| Enrollment ICMJE | 0 |
| Completion Date | January 2013 |
| Primary Completion Date | January 2013 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female |
| Ages | 18 Years to 40 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01129947 |
| Other Study ID Numbers ICMJE | VCRM4 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine |
| Study Sponsor ICMJE | Virginia Center for Reproductive Medicine |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Virginia Center for Reproductive Medicine |
| Verification Date | January 2013 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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