Pulsatile luteinizing hormone amplitude and progesterone metabolite excretion are reduced in obese women.
Akas Jain, Alex J Polotsky, Dana Rochester...
https://pubmed.ncbi.nlm.nih.gov/17440019Actively Recruiting
Phase 2
Age: 18Years - 38Years
FEMALE
Healthy Volunteers
ID06686537
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep
Led by University of Colorado, Denver · Updated on 2025-05-01
20
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
C
Colorado Clinical & Translational Sciences Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how obesity affects hormone responses in pre-menopausal women aged 18 to 40 with regular menstrual cycles. The study aims to understand whether obese women have a reduced response to estradiol that affects luteinizing hormone (LH) surges at the pituitary and hypothalamus levels. This research explores differences in hormone sensitivity related to body weight and reproductive hormone regulation. Participants are divided into two groups based on body mass index (BMI): normal weight women and women with BMI over 30. Both groups will wear transdermal estradiol patches for 7 days. During this time, participants will collect daily morning urine samples and have a blood draw on the third day of wearing the patch to measure hormone levels and LH surge timing. The study includes a screening period of up to 3 weeks to confirm eligibility, followed by a treatment period lasting 7 to 10 days. Participants will be monitored for luteinizing hormone surge amount and timing during treatment. They must use reliable birth control or abstain from intercourse throughout the study. Blood tests, urine collection, and hormone level assessments will help researchers evaluate hormone responses and safety during the trial.
CONDITIONS
Brief Title
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
Who Can Participate
Age: 18Years - 38Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18-38
- Regular menstrual cycles every 25-35 days
- No use of reproductive hormones within the past 3 months
- No use of medications interacting with reproductive hormones
- Agreement to use reliable barrier contraception or to abstain from intercourse for the duration of the study
- Normal thyroid stimulating hormone, prolactin and lipid profiles
- No more than 4 hours of moderate to vigorous intensity exercise per week
- No history of chronic disease impacting reproductive hormones
- No contraindications to administration of estradiol
- No history of estrogen dependent cancer
- Negative pregnancy test
You will not qualify if you...
- Has diabetes
- Is a smoker
- History of venous thromboembolism or known thrombophilia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Treatment
Duration - 7 to 10 days
Participants wear estradiol patches for up to 7 days and collect daily morning urine to determine luteinizing hormone surge. A blood draw is performed on day 3 of patch use.
1 baseline visit and daily urine collection with 1 blood draw visit on day 3
Trial Site Locations
Total: 2 locations
1
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Not Yet Recruiting
2
University of Colorado-School of Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
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Research Team
K
Katherine Kuhn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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Published Research Related To This Trial
Induction of the LH Surge in Premenarchal Girls Confirms Early Maturation of the Hypothalamic-Pituitary-Ovarian Axis.
Polina Rovner, Julia Keltz, Amanda Allshouse...
https://pubmed.ncbi.nlm.nih.gov/29153058