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Infertility, FemalePhase 2NCT06686537

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

A Phase 2 study testing Estradiol Patches in people with Infertility, Female and Obesity, run by University of Colorado, Denver at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 38 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Female, Obesity
What is being tested?
Estradiol Patches
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
25 Feb 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 38 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • Has diabetes
  • Is a smoker
  • History of venous thromboembolism or known thrombophilia

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carrie Hsu contact

303-724-5276

Carire.Hsu@cuanschutz.edu

Asma Giornazi contact

asma.giornazi@cuanschutz.edu

United States2 sites, 2 recruiting

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado-School of Medicine

    Aurora, Colorado, 80045

    Asma Giornazi, MS, 303-724-5276, Asma.Giornazi@cuanschutz.edu

    Recruiting

Other trials in United States

About this study

Official title: Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep

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.

Read the 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.

Being tested
Estradiol Patches
Keywords
Obesity, Infertility, Hypothalamic-pituitary-ovarian axis, pituitary dysfunction
Medical subject headings
Infertility, Female, Obesity, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estradiol PatchesDrug

    Estradiol patched will be worn for 7 days.

Study groups in NCT06686537
Study groupRoleWhat they receive
Estradiol Patch- Normal Weight womenExperimentalNormal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
Receives: Drug: Estradiol Patches
Estradiol Patch- Women with high BMIExperimentalWomen with a BMI greater than 30 kg/m2 will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
Receives: Drug: Estradiol Patches

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of Luteinizing hormone Surge

    Urinary luteinizing hormone concentration in mIU/mg of Creatinine

    Measured: From enrollment to the end of treatment is 7 days.

Secondary outcomes (1)

  1. Time of Luteinizing Hormone Peak

    Specific day of highest urinary luteinizing hormone concentration (in days)

    Measured: From enrollment to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start25 Feb 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06686537
Sponsor's protocol ID
24-1269
Other IDs
CO-C-24-218
Status last verified
Jul 2026
First submitted
11 Nov 2024
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 29153058

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Estradiol Patches in people with Infertility, Female and Obesity, run by University of Colorado, Denver at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carrie Hsu (303-724-5276, Carire.Hsu@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of Luteinizing hormone Surge (time frame: From enrollment to the end of treatment is 7 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06686537, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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