We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05061472
Recruitment Status : Recruiting
First Posted : September 29, 2021
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease
Contraceptive Usage Overweight or Obesity Body Weight Changes Appetitive Behavior Eating Behavior

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Combined Oral Contraceptives on Weight, Body Composition, Eating Behaviors, and Appetite in Pre-menopausal Women With Overweight or Obesity
Actual Study Start Date : May 23, 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort
COC
Pre-menopausal women with overweight or obesity who are newly initiating the combined oral contraceptive pill, Sprintec (norgestimate/ethinyl estradiol 0.25mg/35mcg)
NHC
Pre-menopausal women with overweight or obesity who are using non-hormonal methods of birth control



Primary Outcome Measures :
  1. Number of pre-menopausal women with overweight or obesity who will initiate a COC vs. continue NHCs, enroll and remain in this study, and complete outcome measures [ Time Frame: Baseline, month 3, month 6 (end of study) ]
    The investigators aim to recruit ~10 women per month for 6 months (N=64; n=32 COCs, n=32 LNG-IUDs; >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.


Biospecimen Retention:   Samples With DNA
Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
The study will be performed in a cohort of up to 64 females of reproductive age, age 18-40 years, with overweight or class I-III obesity (BMI 25-45 kg/m2) who initiate the Sprintec COC pill or remain on a NHC
Criteria

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
  • Planning to change diet or join a weight loss program or research study within the next 6 months
  • Recent therapeutic abortion or miscarriage in the past 1 month if fetal gestational age <10 weeks, or 3 months if fetal gestational age >10 weeks
  • Pregnancy with delivery in the past 6 months
  • Currently lactating
  • Transmen who were assigned female at birth and either currently using or planning to use gender-affirming hormone therapy in the next 6 months
  • Use of other forms of reproductive hormones such as testosterone or dehydroepiandrosterone (DHEA)
  • Current tobacco use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05061472


Contacts
Layout table for location contacts
Contact: Kelsey J Sloggett, MS 313.460.8011 kelsey.jones@cuanschtuz.edu
Contact: Sheila Steinke, MS 303.724.3304 sheila.steinke@cuanschutz.edu

Locations
Layout table for location information
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Sheila Steinke    303-724-3304    Sheila.Steinke@CUAnschutz.edu   
Comprehensive Women's Health Center Recruiting
Denver, Colorado, United States, 80230
Contact: Eva Dindinger    303-724-8576    Eva.Dindinger@CUAnschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Adnin Zaman, MD University of Colorado, Denver
Study Chair: Victoria A Catenacci, MD University of Colorado, Denver
Study Chair: Elizabeth A Thomas, MD University of Colorado, Denver
Study Chair: Aaron Lazorwitz, MD University of Colorado, Denver
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05061472    
Other Study ID Numbers: 21-3969
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Combined Oral Contraceptive Pill
Body Weight
Body Composition
Eating Behaviors
Appetite
Pre-menopausal Women
Overweight
Obesity
Non-Hormonal Contraception
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Body Weight
Overweight
Body Weight Changes
Overnutrition
Nutrition Disorders