Trial Outcomes & Findings for Feasibility Study for Development of an Early Test for Ovarian Failure (NCT NCT00006156)

NCT ID: NCT00006156

Last Updated: 2013-05-16

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

24 hours

Results posted on

2013-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Drug - FSH	Control
Overall Study STARTED	42	7
Overall Study COMPLETED	42	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study for Development of an Early Test for Ovarian Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drug - FSH n=42 Participants	Control n=7 Participants	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=99 Participants	7 Participants n=107 Participants	48 Participants n=206 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Female	42 Participants n=99 Participants	7 Participants n=107 Participants	49 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=99 Participants	4 Participants n=107 Participants	44 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	7 Participants n=99 Participants	0 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	5 Participants n=99 Participants	1 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) White	29 Participants n=99 Participants	3 Participants n=107 Participants	32 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	Drug - FSH n=42 Participants	Control n=7 Participants
Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels. Baseline	50.7 participants Standard Error 3.7	48.8 participants Standard Error 8.8
Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels. 24 Hours	96.6 participants Standard Error 7.9	47.7 participants Standard Error 10.7

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	Drug - FSH n=42 Participants	Control n=7 Participants
Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels Baseline	29.9 participants Standard Error 2.0	25.0 participants Standard Error 3.4
Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels 24 Hours	70.8 participants Standard Error 6.4	28.3 participants Standard Error 6.1

Adverse Events

Adverse Events Not Collected

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

Nelson, Lawrence Merle

National Institute of Child Health and Human Development

Phone: +1 301 402 6608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place