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Effect of Increased Circulating Androgens on Granulosa Cell Responses to FSH.

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ClinicalTrials.gov Identifier: NCT02389088
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : September 28, 2015
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Jeffrey Chang, MD, University of California, San Diego

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Polycystic Ovary Syndrome
Intervention Drug: Letrozole
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I - All Study Participants
Hide Arm/Group Description

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).

Period Title: Overall Study - Phase I
Started 9
Completed 9
Not Completed 0
Period Title: Phase II - All Study Participants
Started 9
Completed 9
Not Completed 0
Arm/Group Title Phase I
Hide Arm/Group Description 9 PCOS women
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
9 PCOS women
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
26  (1.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  11.1%
White
7
  77.8%
More than one race
1
  11.1%
Unknown or Not Reported
0
   0.0%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
[1]
Measure Description: San Diego
Phase I - LH, FSH  
Mean (Standard Deviation)
Unit of measure:  IU/L
Number Analyzed 9 participants
LH 9.5  (4.04)
FSH 5.1  (1.03)
Phase I - Testosterone, Androstenedione, 17-OH Progesterone  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 9 participants
Testosterone 1.34  (0.3)
Androstenedione 5.29  (1.3)
17-OH Progesterone 47.3  (24.6)
Phase I - Estradiol  
Mean (Standard Deviation)
Unit of measure:  pmol/L
Number Analyzed 9 participants
180.4  (25.5)
Phase II - LH, FSH  
Mean (Standard Deviation)
Unit of measure:  IU/L
Number Analyzed 9 participants
LH 8.6  (4.4)
FSH 4.7  (1.3)
Phase II - Testosterone, Androstenedione, 17-OH Progesterone  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 9 participants
Testosterone 1.3  (0.4)
Androstenedione 5.5  (1.6)
17-OH Progesterone 53.3  (43.7)
Phase II - Estradiol  
Mean (Standard Deviation)
Unit of measure:  pmol/L
Number Analyzed 9 participants
195.7  (97.4)
1.Primary Outcome
Title Estradiol During Phase I and Phase II
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I and Phase II - PCOS patients.
Arm/Group Title Phase I - Week 0 - 24 Hours Phase I - Week 5 - 0 Hour Phase I - Week 5 - 24 Hour Phase I - Week 6 - 0 Hour Phase I - Week 6 - 24 Hour Phase II - Week 0 - 24 Hours Phase II - Week 5 - 0 Hours Phase II - Week 5 - 24 Hours Phase II - Week 6 - 0 Hours Phase II - Week 6 - 24 Hours
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 9 9 9 9 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: pmol/L
451.7  (131) 116  (27.8) 247.2  (105.5) 131.4  (20.2) 347.5  (83.9) 401.4  (103.4) 57.9  (27) 91.3  (80.8) 66.5  (36.6) 126.6  (117.7)
2.Primary Outcome
Title Inhibin B During Phase I and Phase II
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I and Phase II - PCOS patients.
Arm/Group Title Phase I - Week 0 - 24 Hours Phase I - Week 5 - 0 Hour Phase I - Week 5 - 24 Hour Phase I - Week 6 - 0 Hour Phase I - Week 6 - 24 Hour Phase II - Week 0 - 24 Hours Phase II - Week 5 - 0 Hours Phase II - Week 5 - 24 Hours Phase II - Week 6 - 0 Hours Phase II - Week 6 - 24 Hours
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 9 9 9 9 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: ng/L
420.6  (120) 87.9  (76.5) 395.1  (186.5) 85.2  (40.2) 445.5  (169) 390  (142.4) 165.2  (202.7) 340  (309) 184.3  (192.1) 427.3  (260)
3.Primary Outcome
Title LH and FSH During Phase I and Phase II
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I and Phase II - PCOS patients.
Arm/Group Title Phase I - Week 0 - 24 Hours Phase I - Week 5 - 0 Hour Phase I - Week 5 - 24 Hour Phase I - Week 6 - 0 Hour Phase I - Week 6 - 24 Hour Phase II - Week 0 - 24 Hours Phase II - Week 5 - 0 Hours Phase II - Week 5 - 24 Hours Phase II - Week 6 - 0 Hours Phase II - Week 6 - 24 Hours
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 9 9 9 9 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: IU/L
LH NA [1]   (NA) 0.6  (0.8) NA [1]   (NA) 2.0  (2.0) NA [1]   (NA) NA [1]   (NA) 1.22  (1.8) NA [1]   (NA) 3.6  (3.9) NA [1]   (NA)
FSH NA [1]   (NA) 3.5  (1.2) NA [1]   (NA) 4.3  (0.9) NA [1]   (NA) NA [1]   (NA) 8.0  (2.6) NA [1]   (NA) 9.3  (3.1) NA [1]   (NA)
[1]
Stimulated value not measured.
4.Primary Outcome
Title Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I and Phase II - PCOS patients.
Arm/Group Title Phase I - Week 0 - 24 Hours Phase I - Week 5 - 0 Hour Phase I - Week 5 - 24 Hour Phase I - Week 6 - 0 Hour Phase I - Week 6 - 24 Hour Phase II - Week 0 - 24 Hours Phase II - Week 5 - 0 Hours Phase II - Week 5 - 24 Hours Phase II - Week 6 - 0 Hours Phase II - Week 6 - 24 Hours
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 9 9 9 9 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: nmol/L
Testosterone NA [1]   (NA) 0.6  (0.2) NA [1]   (NA) 0.8  (0.4) NA [1]   (NA) NA [1]   (NA) 0.6  (0.2) NA [1]   (NA) 0.01  (0.44) NA [1]   (NA)
Androstenedione NA [1]   (NA) 2.8  (0.9) NA [1]   (NA) 3.6  (1.0) NA [1]   (NA) NA [1]   (NA) 2.9  (0.8) NA [1]   (NA) 4.3  (1.9) NA [1]   (NA)
17OH-Progesterone NA [1]   (NA) 32.1  (17.5) NA [1]   (NA) 31.1  (9.8) NA [1]   (NA) NA [1]   (NA) 24.0  (16.1) NA [1]   (NA) 37.4  (22.1) NA [1]   (NA)
[1]
Stimulated values not measured
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I Phase II
Hide Arm/Group Description

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).

Women that participated in Phase I will be studied again after a washout of 2 months. On study day one, an FSH stimulation test will be performed as described above.

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. Four weeks after administration of Lupron, each subject will receive Letrozole 5mg for 14 days. The FSH stimulation test will be repeated at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function).

Letrozole: In Phase II, letrozole, 5 mg/day, will be given for 14 days

All-Cause Mortality
Phase I Phase II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase I Phase II
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I Phase II
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. R. Jeffrey Chang
Organization: University of California, San Diego
Phone: 858-534-8930
EMail: rjchang@ucsd.edu
Layout table for additonal information
Responsible Party: Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02389088     History of Changes
Other Study ID Numbers: UCSD-2016
First Submitted: March 9, 2015
First Posted: March 17, 2015
Results First Submitted: May 26, 2015
Results First Posted: September 28, 2015
Last Update Posted: March 10, 2016