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| ID | Type | Description | Link |
|---|---|---|---|
| CO-C-24-218 | Other Identifier | U of Colorado CCTSI |
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| Name | Class |
|---|---|
| Colorado Clinical & Translational Sciences Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estradiol Patch- Normal Weight women | Experimental | Normal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge. |
|
| Estradiol Patch- Women with high BMI | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol Patches | Drug | Estradiol patched will be worn for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Luteinizing hormone Surge | Urinary luteinizing hormone concentration in mIU/mg of Creatinine | From enrollment to the end of treatment is 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Luteinizing Hormone Peak | Specific day of highest urinary luteinizing hormone concentration (in days) | From enrollment to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility is limited to only female (assigned at birth) participants due to the requirement for menstruating females.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine Kuhn | Contact | 303-724-5276 | Katherine.Kuhn@cuanshcutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nanette Santoro, MD | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine | Not yet recruiting | Aurora | Colorado | 80045 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17440019 | Background | 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. | |
| 29153058 | Background |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D009765 | Obesity |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| University of Colorado-School of Medicine |
| Recruiting |
| Aurora |
| Colorado |
| 80045 |
| United States |
|
| 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. |
| D000091662 | Genital Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |