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NCT05061472 · ClinicalTrials.gov registry record
A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 20
- Enrollment target
NCT05061472 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 20 participants.
The verdict
NCT05061472 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
Approximately 15 million women of reproductive age women in the United States have overweight or obesity and use the combined estrogen and progestin oral contraceptive pill (COC). Although many women report weight gain as a side effect of COCs, a conclusive link between COC use and weight gain has not been established. This investigation will address a major gap in the literature by prospectively evaluating the influence of initiating a COC versus non-hormonal contraceptives (NHCs) on weight, body composition, eating behaviors, and appetite in pre-menopausal women with overweight or obesity. Aim 1 will assess the feasibility of recruiting and retaining a racially/ethnically diverse group of women with overweight and obesity while Aim 2 will explore changes in body weight, body composition, and cardiometabolic risks in these women; Aim 3 will explore changes in dietary and macronutrient energy intake, eating behaviors, and appetite in this subset of women. This research will help the investigators understand the extent to which COCs are associated with weight gain and help guide medical providers in counseling women with overweight and obesity on appropriate contraceptive methods.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-05-23 |
| Est. Completion | 2023-08-23 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05061472
The ClinicalTrials.gov registry entry for NCT05061472 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT05061472 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05061472 about?
NCT05061472 is a clinical study titled "A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity". Approximately 15 million women of reproductive age women in the United States have overweight or obesity and use the combined estrogen and progestin oral contraceptive pill (COC). Although many women report weight gain as a side effect of COCs, a conclusive link between COC use and weight gain has n...
What is the current status of trial NCT05061472?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2022-05-23. Estimated completion is 2023-08-23.
Who is sponsoring clinical trial NCT05061472?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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