NCT06686537|RecruitingPhase 2FDA Drug
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Sponsor study identifier
Secondary identifiers
OTHER · U of Colorado CCTSI
interventional
20
1 country
2
Study Start
February 25, 2025
Actual (reported)Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 11, 2024
Actual (reported)November 13, 2024
Actual (reported)February 25, 2025
Actual (reported)October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Amount of Luteinizing hormone Surge
Urinary luteinizing hormone concentration in mIU/mg of Creatinine
From enrollment to the end of treatment is 7 days.
Time of Luteinizing Hormone Peak
From enrollment to 7 days
Normal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
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.
Estradiol patched will be worn for 7 days.
University of Colorado School of Medicine
Aurora, Colorado, 80045, United States
University of Colorado-School of Medicine
Aurora, Colorado, 80045, United States
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.
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.
Nanette Santoro, MD
University of Colorado School of Medicine
First Submitted
November 11, 2024
First Posted
November 13, 2024
Study Start
February 25, 2025
Actual (reported)Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
Contact the study team to confirm eligibility.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 21, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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