Trial Outcomes & Findings for Effect of Increased Circulating Androgens on Granulosa Cell Responses to FSH. (NCT NCT02389088)
NCT ID: NCT02389088
Last Updated: 2016-03-10
Results Overview
Estradiol (pmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II
Results posted on
2016-03-10
Participant Flow
Participant milestones
| Measure |
Phase I - All Study Participants
9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.
The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function).
|
|---|---|
|
Overall Study - Phase I
STARTED
|
9
|
|
Overall Study - Phase I
COMPLETED
|
9
|
|
Overall Study - Phase I
NOT COMPLETED
|
0
|
|
Phase II - All Study Participants
STARTED
|
9
|
|
Phase II - All Study Participants
COMPLETED
|
9
|
|
Phase II - All Study Participants
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Increased Circulating Androgens on Granulosa Cell Responses to FSH.
Baseline characteristics by cohort
| Measure |
Phase I
n=9 Participants
9 PCOS women
|
|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
|
Phase I - LH, FSH
LH
|
9.5 IU/L
STANDARD_DEVIATION 4.04 • n=5 Participants
|
|
Phase I - LH, FSH
FSH
|
5.1 IU/L
STANDARD_DEVIATION 1.03 • n=5 Participants
|
|
Phase I - Testosterone, Androstenedione, 17-OH Progesterone
Testosterone
|
1.34 nmol/L
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Phase I - Testosterone, Androstenedione, 17-OH Progesterone
Androstenedione
|
5.29 nmol/L
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Phase I - Testosterone, Androstenedione, 17-OH Progesterone
17-OH Progesterone
|
47.3 nmol/L
STANDARD_DEVIATION 24.6 • n=5 Participants
|
|
Phase I - Estradiol
|
180.4 pmol/L
STANDARD_DEVIATION 25.5 • n=5 Participants
|
|
Phase II - LH, FSH
LH
|
8.6 IU/L
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Phase II - LH, FSH
FSH
|
4.7 IU/L
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Phase II - Testosterone, Androstenedione, 17-OH Progesterone
Testosterone
|
1.3 nmol/L
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Phase II - Testosterone, Androstenedione, 17-OH Progesterone
Androstenedione
|
5.5 nmol/L
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Phase II - Testosterone, Androstenedione, 17-OH Progesterone
17-OH Progesterone
|
53.3 nmol/L
STANDARD_DEVIATION 43.7 • n=5 Participants
|
|
Phase II - Estradiol
|
195.7 pmol/L
STANDARD_DEVIATION 97.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase IIPopulation: Phase I and Phase II - PCOS patients.
Estradiol (pmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.
Outcome measures
| Measure |
Phase I - Week 0 - 24 Hours
n=9 Participants
|
Phase I - Week 5 - 0 Hour
n=9 Participants
|
Phase I - Week 5 - 24 Hour
n=9 Participants
|
Phase I - Week 6 - 0 Hour
n=9 Participants
|
Phase I - Week 6 - 24 Hour
n=9 Participants
|
Phase II - Week 0 - 24 Hours
n=9 Participants
|
Phase II - Week 5 - 0 Hours
n=9 Participants
|
Phase II - Week 5 - 24 Hours
n=9 Participants
|
Phase II - Week 6 - 0 Hours
n=9 Participants
|
Phase II - Week 6 - 24 Hours
n=9 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Estradiol During Phase I and Phase II
|
451.7 pmol/L
Standard Deviation 131
|
116 pmol/L
Standard Deviation 27.8
|
247.2 pmol/L
Standard Deviation 105.5
|
131.4 pmol/L
Standard Deviation 20.2
|
347.5 pmol/L
Standard Deviation 83.9
|
401.4 pmol/L
Standard Deviation 103.4
|
57.9 pmol/L
Standard Deviation 27
|
91.3 pmol/L
Standard Deviation 80.8
|
66.5 pmol/L
Standard Deviation 36.6
|
126.6 pmol/L
Standard Deviation 117.7
|
PRIMARY outcome
Timeframe: At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase IIPopulation: Phase I and Phase II - PCOS patients.
Inhibin B (ng/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.
Outcome measures
| Measure |
Phase I - Week 0 - 24 Hours
n=9 Participants
|
Phase I - Week 5 - 0 Hour
n=9 Participants
|
Phase I - Week 5 - 24 Hour
n=9 Participants
|
Phase I - Week 6 - 0 Hour
n=9 Participants
|
Phase I - Week 6 - 24 Hour
n=9 Participants
|
Phase II - Week 0 - 24 Hours
n=9 Participants
|
Phase II - Week 5 - 0 Hours
n=9 Participants
|
Phase II - Week 5 - 24 Hours
n=9 Participants
|
Phase II - Week 6 - 0 Hours
n=9 Participants
|
Phase II - Week 6 - 24 Hours
n=9 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Inhibin B During Phase I and Phase II
|
420.6 ng/L
Standard Deviation 120
|
87.9 ng/L
Standard Deviation 76.5
|
395.1 ng/L
Standard Deviation 186.5
|
85.2 ng/L
Standard Deviation 40.2
|
445.5 ng/L
Standard Deviation 169
|
390 ng/L
Standard Deviation 142.4
|
165.2 ng/L
Standard Deviation 202.7
|
340 ng/L
Standard Deviation 309
|
184.3 ng/L
Standard Deviation 192.1
|
427.3 ng/L
Standard Deviation 260
|
PRIMARY outcome
Timeframe: At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase IIPopulation: Phase I and Phase II - PCOS patients.
LH and FSH (IU/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.
Outcome measures
| Measure |
Phase I - Week 0 - 24 Hours
n=9 Participants
|
Phase I - Week 5 - 0 Hour
n=9 Participants
|
Phase I - Week 5 - 24 Hour
n=9 Participants
|
Phase I - Week 6 - 0 Hour
n=9 Participants
|
Phase I - Week 6 - 24 Hour
n=9 Participants
|
Phase II - Week 0 - 24 Hours
n=9 Participants
|
Phase II - Week 5 - 0 Hours
n=9 Participants
|
Phase II - Week 5 - 24 Hours
n=9 Participants
|
Phase II - Week 6 - 0 Hours
n=9 Participants
|
Phase II - Week 6 - 24 Hours
n=9 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
LH and FSH During Phase I and Phase II
LH
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
0.6 IU/L
Standard Deviation 0.8
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
2.0 IU/L
Standard Deviation 2.0
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
1.22 IU/L
Standard Deviation 1.8
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
3.6 IU/L
Standard Deviation 3.9
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
|
LH and FSH During Phase I and Phase II
FSH
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
3.5 IU/L
Standard Deviation 1.2
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
4.3 IU/L
Standard Deviation 0.9
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
8.0 IU/L
Standard Deviation 2.6
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
9.3 IU/L
Standard Deviation 3.1
|
NA IU/L
Standard Deviation NA
Stimulated value not measured.
|
PRIMARY outcome
Timeframe: At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase IIPopulation: Phase I and Phase II - PCOS patients.
Testosterone, Androstenedione and 17-OH Progesterone (nmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.
Outcome measures
| Measure |
Phase I - Week 0 - 24 Hours
n=9 Participants
|
Phase I - Week 5 - 0 Hour
n=9 Participants
|
Phase I - Week 5 - 24 Hour
n=9 Participants
|
Phase I - Week 6 - 0 Hour
n=9 Participants
|
Phase I - Week 6 - 24 Hour
n=9 Participants
|
Phase II - Week 0 - 24 Hours
n=9 Participants
|
Phase II - Week 5 - 0 Hours
n=9 Participants
|
Phase II - Week 5 - 24 Hours
n=9 Participants
|
Phase II - Week 6 - 0 Hours
n=9 Participants
|
Phase II - Week 6 - 24 Hours
n=9 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II
Testosterone
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
0.6 nmol/L
Standard Deviation 0.2
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
0.8 nmol/L
Standard Deviation 0.4
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
0.6 nmol/L
Standard Deviation 0.2
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
0.01 nmol/L
Standard Deviation 0.44
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
|
Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II
Androstenedione
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
2.8 nmol/L
Standard Deviation 0.9
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
3.6 nmol/L
Standard Deviation 1.0
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
2.9 nmol/L
Standard Deviation 0.8
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
4.3 nmol/L
Standard Deviation 1.9
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
|
Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II
17OH-Progesterone
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
32.1 nmol/L
Standard Deviation 17.5
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
31.1 nmol/L
Standard Deviation 9.8
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
24.0 nmol/L
Standard Deviation 16.1
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
37.4 nmol/L
Standard Deviation 22.1
|
NA nmol/L
Standard Deviation NA
Stimulated values not measured
|
Adverse Events
Phase I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II
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
University of California, San Diego
Phone: 858-534-8930
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place