Status:
COMPLETED
Mediators of Abnormal Reproductive Function in Obesity (MARO)
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infertility, Female
Obesity
Eligibility:
FEMALE
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
The study is seeking to understand how being overweight and obese makes women less fertile. The studies the investigators have done so far indicate that there is a hormone or other substance produced ...
Detailed Description
Specific Aim 1: To determine whether aromatase activity is measurable in adipose tissue using the 'compound' (see appendix) as a precursor and whether aromatase is decreased in the adipose tissue of o...
Eligibility Criteria
Inclusion
- Women aged 18-39\* who meet the following criteria will be enrolled:
- \*Women age 40-60 can be enrolled in Group A
- BMI at least 30 kg/m2 (Groups B and C only)
- No history of chronic disease affecting hormone production, metabolism or clearance
- No use of medications known to alter or interact with reproductive hormones or insulin metabolism (e.g. thiazolidinediones, metformin)
- No use of reproductive hormones within 3 months of enrollment
- No medical conditions that are known to affect urinary hormone excretion or that may interfere with urinary hormone measurement (Groups B and C only)
- No history of or active bladder cancer (Group C only, since pioglitazone is contraindicated in individuals with bladder cancer)
- Normal prolactin and thyroid stimulating hormone levels at screening
- History of regular menstrual cycles every 25-40 days
- Use of a reliable method of contraception (female or male partner sterilization; intrauterine device (IUD); abstinence; diaphragm)
- Hemoglobin A1c \<6%
Exclusion
- Women aged 18-39\* who meet the following criteria will be enrolled:
- \*Women age 40-60 can be enrolled in Group A
- BMI at least 30 kg/m2 (Groups B and C only)
- No history of chronic disease affecting hormone production, metabolism or clearance
- No use of medications known to alter or interact with reproductive hormones or insulin metabolism (e.g. thiazolidinediones, metformin)
- No use of reproductive hormones within 3 months of enrollment
- No medical conditions that are known to affect urinary hormone excretion or that may interfere with urinary hormone measurement (Groups B and C only)
- No history of or active bladder cancer (Group C only, since pioglitazone is contraindicated in individuals with bladder cancer)
- Normal prolactin and thyroid stimulating hormone levels at screening
- History of regular menstrual cycles every 25-40 days
- Use of a reliable method of contraception (female or male partner sterilization; IUD; abstinence; diaphragm)
- Hemoglobin A1c \<6%
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01817400
Start Date
March 1 2013
End Date
December 1 2014
Last Update
March 17 2015
Active Locations (1)
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1
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States, 80045