Trial Outcomes & Findings for Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF) (NCT NCT00948857)

NCT ID: NCT00948857

Last Updated: 2012-09-10

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 5 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2012-09-10

Participant Flow

Participant milestones

Measure	Dehydroepiandrosterone 25 mg Tid po Dehydroepiandrosterone 25 mg tid po	Blinded Placebo Blinded placebo
Overall Study STARTED	3	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Dehydroepiandrosterone 25 mg Tid po Dehydroepiandrosterone 25 mg tid po	Blinded Placebo Blinded placebo
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)

Baseline characteristics by cohort

Measure	Dehydroepiandrosterone 25 mg Tid po n=3 Participants Dehydroepiandrosterone 25 mg tid po	Blinded Placebo n=2 Participants Blinded placebo	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	38 years STANDARD_DEVIATION 3 • n=5 Participants	38 years STANDARD_DEVIATION 3 • n=7 Participants	38 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 9 months

Population: This study was closed for futility because of difficulty finding patients willing to undergo randomization.

Live Birth outcome compared between DHEA active treatment and Placebo

Outcome measures

Measure	DHEA n=3 Participants Dehydroepiandrosterone 25 mg tid po	Placebo n=2 Participants Blinded placebo
Live Birth	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

Adverse Events

Dehydroepiandrosterone 25 mg Tid po

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blinded Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Norbert Gleicher

Center for Human Reproduction

Phone: 212-994-4400

Email: ngleicher@thechr.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place