Trial Outcomes & Findings for Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS) (NCT NCT00747617)

NCT ID: NCT00747617

Last Updated: 2018-11-21

Results Overview

Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 25 participants
• Primary outcome timeframe: 24 hrs post dose
• Results posted on: 2018-11-21

Participant Flow

Subjects recruited from UCSD clinics and coal advertising beginning in 2009 and ending in 2010

Subjects involved women with PCOS and normal control women undergoing hCG stimulation

Participant milestones

Measure	PCOS Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.	Normal Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
Overall Study STARTED	13	12
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	PCOS Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.	Normal Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)

Baseline characteristics by cohort

Measure	PCOS n=13 Participants Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.	Normal n=12 Participants Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.	Total n=25 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	13 Participants n=5 Participants	12 Participants n=7 Participants	25 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	28.5 years STANDARD_DEVIATION 1.1 • n=5 Participants	30 years STANDARD_DEVIATION 1.3 • n=7 Participants	29 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 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	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hrs post dose

Population: PCOS and Normal groups were analyzed according to peak 17OHP levels at each dose of r-hCG.

Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects

Outcome measures

Measure	PCOS n=10 Participants Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.	Normal n=11 Participants Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
Serum 17OHP Responses to hCG 17OHP post 10 micrograms	2.0 ng/ml Standard Error 0.3	1.2 ng/ml Standard Error 0.1
Serum 17OHP Responses to hCG 17OHP level post 1 micrograms	1.1 ng/ml Standard Error 0.1	1.0 ng/ml Standard Error 0.1
Serum 17OHP Responses to hCG 17OHP level post 25 micrograms	2.7 ng/ml Standard Error 0.3	1.7 ng/ml Standard Error 0.2
Serum 17OHP Responses to hCG 17OHP level post 100 micrograms	3.3 ng/ml Standard Error 0.6	2.2 ng/ml Standard Error 0.3
Serum 17OHP Responses to hCG 17OHP level post 250 micrograms	4.0 ng/ml Standard Error 0.6	2.1 ng/ml Standard Error 0.4

SECONDARY outcome

Timeframe: -0.5, 0, 24 hrs

Mean serum testosterone levels before and after hCG injection. Serum testosterone levels before (-0.5 and 0 hrs) were averaged to achieve a single value

Outcome measures

Measure	PCOS n=10 Participants Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.	Normal n=11 Participants Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
Serum Testosterone Responses to hCG	0.6 ng/ml Standard Error 0.1	0.3 ng/ml Standard Error 0.05

Adverse Events

PCOS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal

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

R. Jeffrey Chang, M.D.

UCSD School of Medicine

Phone: 858-534-8930

Email: rjchang@ucsd.edu

Results disclosure agreements

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