Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Estradiol Patches.
- Who it may be relevant to
- Registry conditions: Infertility, Female, Obesity. Basic parameters: 18 years — 38 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep
Overview
Dr. Nanette Santoro proposes to test the specific question that obesity results in abnormal estradiol response at the level of the pituitary and hypothalamus. This will be shown in diminished pituitary sensitivity to gonadorelin releasing hormone with a reduced estradiol induced luteinizing hormone surge in obese women.
Detailed description
This is an open-label, single site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of normal BMI or high BMI. The objective of the study is to determine the effects of an estradiol patch on luteinizing hormone rise in both cohorts. The study consists of 2 periods: a screening period of up to 3 weeks and a Treatment Period of 7-10 days. During the treatment period participants will wear estradiol patches for up to 7 days and have on blood draw on day 3 of wearing the patches. Participants will also collect daily morning urine for all the days they wear the patches. Participants will use a reliable barrier method of birth control or abstain from intercourse for the duration of the study.
Interventions
- Drug Estradiol Patches
Estradiol patched will be worn for 7 days.
Primary outcome measures
- Amount of Luteinizing hormone Surge [Time frame: From enrollment to the end of treatment is 7 days.]
Secondary outcome measures (1)
- Time of Luteinizing Hormone Peak [Time frame: From enrollment to 7 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Has diabetes
- Is a smoker
- History of venous thromboembolism or known thrombophilia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- University of Colorado School of Medicine — Aurora
- University of Colorado-School of Medicine — Aurora
Publications
- Jain A, Polotsky AJ, Rochester D, Berga SL, Loucks T, Zeitlian G, Gibbs K, Polotsky HN, Feng S, Isaac B, Santoro N. Pulsatile luteinizing hormone amplitude and progesterone metabolite excretion are reduced in obese women. J Clin Endocrinol Metab. 2007 Jul;92(7):2468-73. doi: 10.1210/jc.2006-2274. Epub 2007 Apr 17. PMID 17440019
- Rovner P, Keltz J, Allshouse A, Isaac B, Hickmon C, Lesh J, Chosich J, Santoro N. Induction of the LH Surge in Premenarchal Girls Confirms Early Maturation of the Hypothalamic-Pituitary-Ovarian Axis. Reprod Sci. 2018 Jan;25(1):33-38. doi: 10.1177/1933719117741377. Epub 2017 Nov 19. PMID 29153058
Identifiers
NCT: NCT06686537 · 24-1269 · CO-C-24-218