Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

NCTNCT02389088Other idUCSD-2016

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Leuprolide, does not test it. It appears in the summary.

Overview

Status: Completed
Phase: Not applicable
Enrollment: 9 participants (actual)
Sponsor: University of California, San Diego · Other
Design: Not randomized · Open label (no masking)
Countries: Not stated
Start: Apr 2006
Primary completion: Jan 2013
Completion: Jan 2013
First posted: 17 Mar 2015 (estimated)
Last update posted: 10 Mar 2016 (estimated)
Conditions: Polycystic Ovary Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20062008201020122014

N/A
Effect of Increased Circulating Androgens on Granulosa Cell Responses to FSH.
NCT02389088
Apr 2006 to Jan 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate the effect of increased circulating androgens on estradiol production by the granulosa cells in response to FSH stimulus.

Interventions

LetrozoleDrug

Arms2

No intervention
Phase I
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).
Active comparator
Phase II
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).

Primary outcomes4

Outcomes the sponsor listed as primary.

Estradiol During Phase I and Phase II
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
Registry 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.
Inhibin B During Phase I and Phase II
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
Registry 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.
LH and FSH During Phase I and Phase II
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
Registry 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.
Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II
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
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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

Estradiol During Phase I and Phase II

Group	Value (pmol/L)	Spread
Phase I - Week 0 - 24 Hours	451.7	131
Phase I - Week 5 - 0 Hour	116	27.8
Phase I - Week 5 - 24 Hour	247.2	105.5
Phase I - Week 6 - 0 Hour	131.4	20.2
Phase I - Week 6 - 24 Hour	347.5	83.9
Phase II - Week 0 - 24 Hours	401.4	103.4
Phase II - Week 5 - 0 Hours	57.9	27
Phase II - Week 5 - 24 Hours	91.3	80.8
Phase II - Week 6 - 0 Hours	66.5	36.6
Phase II - Week 6 - 24 Hours	126.6	117.7

Primary outcomeMean· 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

Inhibin B During Phase I and Phase II

Group	Value (ng/L)	Spread
Phase I - Week 0 - 24 Hours	420.6	120
Phase I - Week 5 - 0 Hour	87.9	76.5
Phase I - Week 5 - 24 Hour	395.1	186.5
Phase I - Week 6 - 0 Hour	85.2	40.2
Phase I - Week 6 - 24 Hour	445.5	169
Phase II - Week 0 - 24 Hours	390	142.4
Phase II - Week 5 - 0 Hours	165.2	202.7
Phase II - Week 5 - 24 Hours	340	309
Phase II - Week 6 - 0 Hours	184.3	192.1
Phase II - Week 6 - 24 Hours	427.3	260

Primary outcomeMean· 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

LH and FSH During Phase I and Phase II

Group	Value (IU/L)	Spread
Phase I - Week 0 - 24 Hours	NA	NA
Phase I - Week 5 - 0 Hour	0.6	0.8
Phase I - Week 5 - 24 Hour	NA	NA
Phase I - Week 6 - 0 Hour	2.0	2.0
Phase I - Week 6 - 24 Hour	NA	NA
Phase II - Week 0 - 24 Hours	NA	NA
Phase II - Week 5 - 0 Hours	1.22	1.8
Phase II - Week 5 - 24 Hours	NA	NA
Phase II - Week 6 - 0 Hours	3.6	3.9
Phase II - Week 6 - 24 Hours	NA	NA

Primary outcomeMean· 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

Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II

Group	Value (nmol/L)	Spread
Phase I - Week 0 - 24 Hours	NA	NA
Phase I - Week 5 - 0 Hour	0.6	0.2
Phase I - Week 5 - 24 Hour	NA	NA
Phase I - Week 6 - 0 Hour	0.8	0.4
Phase I - Week 6 - 24 Hour	NA	NA
Phase II - Week 0 - 24 Hours	NA	NA
Phase II - Week 5 - 0 Hours	0.6	0.2
Phase II - Week 5 - 24 Hours	NA	NA
Phase II - Week 6 - 0 Hours	0.01	0.44
Phase II - Week 6 - 24 Hours	NA	NA

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Phase I9 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).	–	0 / 9	0 / 9
Phase IIWomen 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	–	0 / 9	0 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedHomer MV, Rosencrantz MA, Shayya RF, Chang RJ. The effect of estradiol on granulosa cell responses to FSH in women with polycystic ovary syndrome. Reprod Biol Endocrinol. 2017 Feb 10;15(1):13. doi: 10.1186/s12958-017-0230-0. PMID 28187771

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Subjects will be determined to have PCOS based on clinical criteria such as history of irregular menses and clinical or laboratory evidence of hyperandrogenism. * Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start. Exclusion Criteria: * Women with hemoglobin less than 11gm/dl at screening evaluation. * Women with untreated thyroid abnormalities * Pregnant women * Women with BMI\>37 * Women with known sensitivity to the agent being used.

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