A Phase 2 interventional study of Estradiol Patches in Infertility, Female and Obesity, sponsored by University of Colorado, Denver. Recruiting at 2 sites in United States. Open to female participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Basic science
Among 65 studies in Infertility, Female with a site in United States — 22 open to participants now, 25 under way, none of them phase 3. Infertility, Female · United States.
Among the 65 studies in Infertility, Female with a site in United States, this one is the 33rd largest by planned enrollment of the 47 interventional ones that give a count, is one of 6 that started in 2025, is one of 2 in phase 2, reaches primary completion later than 14 of the 24 other live ones, and was the 59th registered.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
Browse Infertility, Female studies →22 of the 65 studies in Infertility, Female with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Shady Grove Fertility Reproductive Science Center · Sites in United States
University of Southern California · Sites in United States
Center for Reproductive Health & Gynecology · Sites in United States, Mexico
Johns Hopkins University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 91 Infertility, Female studies recruiting now, 10 (11%) set no upper age limit and 81 (89%) stop at 75 or younger; 9 take children under 18; 30 take healthy volunteers.
This study: 18 Years to 38 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
65 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 4 · Phase 4 6
First in 2004; this study’s year is marked. 6 started in 2025.
This study's planned enrollment of 20 is below the median of 100 across 378 interventional studies indexed under Infertility, Female.
Median enrollment 50 across the 47 interventional studies, 175 across the 18 observational. Of the 32 that completed or were terminated, 7 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 65 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 3 studies filed under Infertility, Female — fewer than ten, so there is no comparison to draw.
5 of the studies in Infertility, Female with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06434233Johns Hopkins UniversityOpioid Use After Laparoscopic Salpingectomy | 2026-11 |
| NCT05997407Virginia Polytechnic Institute and State UniversityThe Effect of a Mindset Management Approach on Stress Levels in Women With Infertility | 2026-12 |
| NCT07858435New Hope Fertility CenterIntra-ovarian CAPA-IVM vs Standard IVM | 2027-03 |
| NCT06686537University of Colorado, DenverConvergent Mechanisms Underlying Reprometabolic Syndrome in Women | 2027-10 |
| NCT04628507Genomic Prediction Inc.Cell Free Preimplantation Genetic Testing | 2027-11-11 |
Among the 65 studies in Infertility, Female with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Normal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
Drug: Estradiol Patches
Women with a BMI greater than 30 kg/m2 will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
Drug: Estradiol Patches
Estradiol patched will be worn for 7 days.
Amount of Luteinizing hormone Surge
Urinary luteinizing hormone concentration in mIU/mg of Creatinine
Time frame: From enrollment to the end of treatment is 7 days.
Time of Luteinizing Hormone Peak
Specific day of highest urinary luteinizing hormone concentration (in days)
Time frame: From enrollment to 7 days
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for Oct 2027, 32 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Estradiol
University of Colorado, Denver →