Trial Outcomes & Findings for Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS) (NCT NCT01154192)

Results Overview

Assess serum levels of 17OHP after stimulation with recombinant hCG

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

24 participants

Primary outcome timeframe

24 hours

Results posted on

2019-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	PCOS Group Intervention: Each subject in the PCOS group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements. Dexamethasone: Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones. recombinant human chorionic gonadotropin (r-hCG): Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection	Normal Group Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements. Dexamethasone
Overall Study STARTED	14	10
Overall Study COMPLETED	14	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCOS Group n=14 Participants Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.	Normal Group n=10 Participants Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.	Oligomenorrhea Group	Total n=24 Participants Total of all reporting groups
Age, Continuous	14.9 years STANDARD_DEVIATION 1.0 • n=14 Participants	15.4 years STANDARD_DEVIATION 1.2 • n=10 Participants	—	15.3 years STANDARD_DEVIATION 1.0 • n=24 Participants
Sex: Female, Male Female	14 Participants n=14 Participants	10 Participants n=10 Participants	—	24 Participants n=24 Participants
Sex: Female, Male Male	0 Participants n=14 Participants	0 Participants n=10 Participants	—	0 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 24 hours

Population: Oligmenorhea group not included in study

Assess serum levels of 17OHP after stimulation with recombinant hCG

Outcome measures

Outcome measures
Measure	PCOS Group n=14 Participants Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.	Normal Group n=10 Participants Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.	Oligomenorrhea Group
17OHP Levels After hCG	3.2 ng/ml Standard Error 0.5	1.3 ng/ml Standard Error 0.3	—

SECONDARY outcome

Timeframe: 24 hours

Population: Oligpmenrreha group not included in study

Assess seruim levels of testosterone after stimulation with recombinant hCG

Outcome measures

Outcome measures
Measure	PCOS Group n=14 Participants Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.	Normal Group n=10 Participants Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.	Oligomenorrhea Group
Testosterone	1.6 ng/ml Standard Error 0.2	1.0 ng/ml Standard Error 0.2	—

SECONDARY outcome

Timeframe: 24 hours

Population: Oligomenorreha group not inlcuded in study

Assess serum levels of androstenedione after stimaultion with recombinant hCG

Outcome measures

Outcome measures
Measure	PCOS Group n=14 Participants Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.	Normal Group n=10 Participants Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.	Oligomenorrhea Group
Androstenedione	2.1 ng/ml Standard Error 0.2	0.9 ng/ml Standard Error 0.2	—

SECONDARY outcome

Timeframe: 24 hours

Population: Oligomenrrhea group not included in study

Assess serum levels of DHEA after stimulation with recombinant hCG

Outcome measures

Outcome measures
Measure	PCOS Group n=14 Participants Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.	Normal Group n=10 Participants Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.	Oligomenorrhea Group
DHEA	1.6 ng/ml Standard Error 0.2	1.0 ng/ml Standard Error 0.2	—

Adverse Events

PCOS Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oligomenorrhea Group

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. R. Jeffrey Chang

UC San Diego School of Medicine

Phone: 858-534-8930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place