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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: Completed study, sponsored by University of Colorado, Denver.
NCT05061472 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The investigators aim to recruit \~10 women per month for 6 months (N=24; n=12 COCs, n=12 NHCs; \>20% in each group of African American or Hispanic race/ethnicity) and assess feasibility of completion of outcome measures. The investigators hypothesize that at least 80% of participants will continue their chosen contraceptive method and complete outcome measures within a 2-week window at 6 months. The 6-month date was calculated as baseline outcome date + 182 days. A 2-week window was considered
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-05-23 |
| Est. Completion | 2023-08-23 |
What the finished NCT05061472 record still lists
NCT05061472 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05061472 does not publish any study locations in the registry export this page uses.
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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