NCT01129947

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2010

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

2.7 years

First QC Date

May 23, 2010

Last Update Submit

January 26, 2013

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

DHEA

EXPERIMENTAL
Drug: DHEA

Interventions

DHEADRUG

DHEA 25 mg tid

DHEA

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with POF

You may not qualify if:

  • women without ovaries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Center for Reproductive Medicine

Reston, Virginia, 20190, United States

Location

Related Publications (1)

  • 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.

    PMID: 19610174BACKGROUND

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

May 23, 2010

First Posted

May 25, 2010

Study Start

May 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

US(1)