A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity

What this trial studies

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.

Conditions in scope

• Contraceptive Usage
• Overweight or Obesity
• Body Weight Changes
• Appetitive Behavior
• Eating Behavior

Interventions

• Not specified in the public record.

Who can join

Women only · Ages 18 Years to 40 Years

Inclusion criteria

• Females
• Age 18-40 years
• Overweight or class I-III obesity (BMI 25-45 kg/m2)
• Free of major psychiatric illnesses
• Electing to start the Sprintec (norgestimate/ethinyl estradiol 0.25mg/35mcg) COC
• Using non-hormonal forms of contraception: copper intrauterine device (Paragard), male condoms, tubal ligation, partner vasectomy, withdrawal/natural family planning, spermicide, abstinence, or other NHCs as determined by the investigators

Exclusion criteria

• Diabetes
• Use of medications thought to affect body weight, energy intake, glycemic parameters, or estrogen (i.e. systemic glucocorticoids, stimulants, weight loss pharmacotherapy, metformin)
• History of weight loss surgery
• History of polycystic ovarian syndrome
• History of congenital adrenal hyperplasia
• Use of a different COC or hormonal contraception method within the past 3 months
• Planning pregnancy
• Planning to stop contraceptive within the next 6 months

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2022-05-23
• Primary completion: 2023-08-23
• Last update posted: 2024-12-11
• First posted: 2021-09-29

Sponsor & contact

Lead sponsor: University of Colorado, Denver (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Number of Premenopausal Women With Overweight/Obesity Who Initiated a COC vs. Continued NHC Use, Enrolled and Remained in This Study, and Completed Outcome Measures (Baseline, Month 6)
  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…

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