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

NCT02389088 | Completed Results

• 1 other identifier: UCSD-2016
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Granulosa Cell; Androgens; FSH; Ovary

Outcome Measures

Primary Outcomes (4)

• Estradiol During Phase I and Phase II

  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.

  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

  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.

  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

  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.

  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

  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.

  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

Study Arms (2)

Phase I

NO INTERVENTION

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).

Phase II

ACTIVE COMPARATOR

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).

Drug: Letrozole

Interventions

Letrozole DRUG

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

Also known as: Femora

Phase II

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Related Publications (1)

• Homer 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 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. R. Jeffrey Chang
• Organization: University of California, San Diego

rjchang@ucsd.edu

858-534-8930

Study Officials

• R. Jeffrey Chang, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus of Reproductive Medicine Division of Reproductive Endocrinology and Infertility

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 17, 2015
• Study Start: April 1, 2006
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 10, 2016
• Results First Posted: September 28, 2015

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share