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/17440019/Actively Recruiting
Led by University of Colorado, Denver · Updated on 2026-07-21
20
Participants Needed
2
Research Sites
8 weeks
Total Duration
Researchers are studying pre-menopausal women aged 18 to 40 years with regular menstrual cycles to understand how obesity affects hormonal responses related to fertility. The focus is on whether obesity leads to a reduced luteinizing hormone surge triggered by estradiol at the pituitary and hypothalamus level. This study aims to compare these hormonal changes between women with normal and high body mass index BMI. Participants will wear estradiol patches for 7 days during the treatment period. There are two groups normal weight women and women with a BMI greater than 30. Both groups will apply the transdermal estradiol patch and collect daily morning urine samples to measure the luteinizing hormone surge. Blood will be drawn on day 3 of patch use to monitor hormone levels. The study includes a screening period lasting up to 3 weeks before treatment. During the study, participants will undergo hormone level assessments through blood draws and urine collection. They must use reliable barrier contraception or abstain from intercourse throughout the trial. Researchers will measure the amount and timing of the luteinizing hormone surge over the 7-day treatment. The total participation time includes screening and treatment phases, with safety monitored through hormone and health assessments.
CONDITIONS
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
C
Carrie Hsu
A
Asma Giornazi
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Colorado, Denver
Lead Sponsor
Colorado Clinical & Translational Sciences Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Estradiol patch (7‑day use) | Usual preconception observation |
|---|---|---|
| What it is | Use of a transdermal estradiol patch for 7 days in women with regular menstrual cycles, comparing normal-weight and high‑BMI groups under single‑group study design | Usual preconception monitoring without estradiol patch intervention |
| Role in trial | All participants receive the estradiol patch intervention; there is no internal comparator arm | This reflects external usual care but is not part of the trial itself |
| Primary use or aim | To determine the effect of estradiol patch on luteinizing‑hormone surge in normal‑weight versus high‑BMI women | Typically involves monitoring menstrual cycle and hormone levels without pharmacologic estradiol supplementation |
| How it is given or performed | Participants apply a transdermal estradiol patch for 7 days | No intervention; evaluation relies on routine menstrual and hormone monitoring |
| Broader evidence status | No published evidence that estradiol patches improve LH surge or fertility in obese women; this trial is generating initial data | Standard evaluation without estradiol supplementation is well‑established but may not address subtle hormonal dynamics in obesity |
| Important risks | Systemic estradiol use may carry known estrogen‑related risks such as venous thromboembolism; safety in this specific setting is not yet established | Routine monitoring without pharmacologic hormone use avoids estrogen‑related systemic risks |
| Important limitations | Single‑group design without concurrent control limits ability to attribute effects; small sample and short duration limit generalizability | Standard care does not modify hormone surge and may not cover mechanistic hormonal differences in obesity; not evaluated within trial |
| Patient impact | Outcomes on LH surge may help understand hormonal differences, but direct fertility or pregnancy benefit is unproven | Routine monitoring helps guide infertility evaluation but may miss hormonal pathway interventions |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 10 days
Participants will wear estradiol patches for 7 days and collect daily morning urine samples. A blood draw will be done on day 3 to monitor hormone levels.
Daily urine collection and 1 blood draw visit
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Akas Jain, Alex J Polotsky, Dana Rochester...
https://pubmed.ncbi.nlm.nih.gov/17440019/Polina Rovner, Julia Keltz, Amanda Allshouse...
https://pubmed.ncbi.nlm.nih.gov/29153058/University of Colorado, Denver
Lead Sponsor
Colorado Clinical & Translational Sciences Institute
Collaborating Sponsor