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

NCT05061472 | Completed Results

• 1 other identifier: 21-3969
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Combined Oral Contraceptive Pill; Body Weight; Body Composition; Eating Behaviors; Appetite; Pre-menopausal Women; Overweight; Obesity; Non-Hormonal Contraception

Outcome Measures

Primary Outcomes (1)

• 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

  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 a +/- 14 days from the calculated 6-month outcome date.

  Baseline, Month 6

Other Outcomes (3)

• Body Weight

  6 Months

• BMI

  6 Months

• Percent Body Fat

  6 Months

Study Arms (2)

Combined Oral Contraceptives

Pre-menopausal women with overweight or obesity who are newly initiating the combined oral contraceptive pill, Sprintec (norgestimate/ethinyl estradiol 0.25mg/35mcg)

Nonhormonal Contraceptives (Control)

Pre-menopausal women with overweight or obesity who are using non-hormonal methods of birth control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• People with pregnancy potential 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Comprehensive Women's Health Center

Denver, Colorado, 80230, United States

Location

Related Publications (16)

• Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.

  PMID: 27272580 BACKGROUND

• Cedergren MI. Maternal morbid obesity and the risk of adverse pregnancy outcome. Obstet Gynecol. 2004 Feb;103(2):219-24. doi: 10.1097/01.AOG.0000107291.46159.00.

  PMID: 14754687 BACKGROUND

• Sebire NJ, Jolly M, Harris JP, Wadsworth J, Joffe M, Beard RW, Regan L, Robinson S. Maternal obesity and pregnancy outcome: a study of 287,213 pregnancies in London. Int J Obes Relat Metab Disord. 2001 Aug;25(8):1175-82. doi: 10.1038/sj.ijo.0801670.

  PMID: 11477502 BACKGROUND

• Koliaki C, Liatis S, Kokkinos A. Obesity and cardiovascular disease: revisiting an old relationship. Metabolism. 2019 Mar;92:98-107. doi: 10.1016/j.metabol.2018.10.011. Epub 2018 Nov 3.

  PMID: 30399375 BACKGROUND

• Coney P, Washenik K, Langley RG, DiGiovanna JJ, Harrison DD. Weight change and adverse event incidence with a low-dose oral contraceptive: two randomized, placebo-controlled trials. Contraception. 2001 Jun;63(6):297-302. doi: 10.1016/s0010-7824(01)00208-6.

  PMID: 11672550 BACKGROUND

• Gallo MF, Lopez LM, Grimes DA, Carayon F, Schulz KF, Helmerhorst FM. Combination contraceptives: effects on weight. Cochrane Database Syst Rev. 2014 Jan 29;2014(1):CD003987. doi: 10.1002/14651858.CD003987.pub5.

  PMID: 24477630 BACKGROUND

• Moore LL, Valuck R, McDougall C, Fink W. A comparative study of one-year weight gain among users of medroxyprogesterone acetate, levonorgestrel implants, and oral contraceptives. Contraception. 1995 Oct;52(4):215-9. doi: 10.1016/0010-7824(95)00189-h.

  PMID: 8605778 BACKGROUND

• Redmond G, Godwin AJ, Olson W, Lippman JS. Use of placebo controls in an oral contraceptive trial: methodological issues and adverse event incidence. Contraception. 1999 Aug;60(2):81-5. doi: 10.1016/s0010-7824(99)00069-4.

  PMID: 10592854 BACKGROUND

• Risser WL, Gefter LR, Barratt MS, Risser JM. Weight change in adolescents who used hormonal contraception. J Adolesc Health. 1999 Jun;24(6):433-6. doi: 10.1016/s1054-139x(98)00151-7.

  PMID: 10401972 BACKGROUND

• Mayeda ER, Torgal AH, Westhoff CL. Weight and body composition changes during oral contraceptive use in obese and normal weight women. J Womens Health (Larchmt). 2014 Jan;23(1):38-43. doi: 10.1089/jwh.2012.4241. Epub 2013 Oct 24.

  PMID: 24156617 BACKGROUND

• Gallo MF, Grimes DA, Schulz KF, Helmerhorst FM. Combination estrogen-progestin contraceptives and body weight: systematic review of randomized controlled trials. Obstet Gynecol. 2004 Feb;103(2):359-73. doi: 10.1097/01.AOG.0000107298.29343.6a.

  PMID: 14754709 BACKGROUND

• Grandi G, Piacenti I, Volpe A, Cagnacci A. Modification of body composition and metabolism during oral contraceptives containing non-androgenic progestins in association with estradiol or ethinyl estradiol. Gynecol Endocrinol. 2014 Sep;30(9):676-80. doi: 10.3109/09513590.2014.922947. Epub 2014 Jun 11.

  PMID: 24918262 BACKGROUND

• Lovett JL, Chima MA, Wexler JK, Arslanian KJ, Friedman AB, Yousif CB, Strassmann BI. Oral contraceptives cause evolutionarily novel increases in hormone exposure: A risk factor for breast cancer. Evol Med Public Health. 2017 Jun 5;2017(1):97-108. doi: 10.1093/emph/eox009. eCollection 2017.

  PMID: 28685096 BACKGROUND

• Fleischman DS, Navarrete CD, Fessler DM. Oral contraceptives suppress ovarian hormone production. Psychol Sci. 2010 May;21(5):750-2; author reply 753. doi: 10.1177/0956797610368062. Epub 2010 Apr 22. No abstract available.

  PMID: 20483856 BACKGROUND

• Leeners B, Geary N, Tobler PN, Asarian L. Ovarian hormones and obesity. Hum Reprod Update. 2017 May 1;23(3):300-321. doi: 10.1093/humupd/dmw045.

  PMID: 28333235 BACKGROUND

• Caldwell AE, Zaman A, Ostendorf DM, Pan Z, Swanson BB, Phelan S, Wyatt HR, Bessesen DH, Melanson EL, Catenacci VA. Impact of Combined Hormonal Contraceptive Use on Weight Loss: A Secondary Analysis of a Behavioral Weight-Loss Trial. Obesity (Silver Spring). 2020 Jun;28(6):1040-1049. doi: 10.1002/oby.22787.

  PMID: 32441474 BACKGROUND

Related Links

• Current Contraceptive Status Among Women Aged 15-49: United States, 2015-2017
• Contraceptive Use in the United States by Demographics

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Contraception Behavior; Overweight; Obesity; Body Weight Changes; Appetitive Behavior; Feeding Behavior; Body Weight

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal

Results Point of Contact

• Title: Adnin Zaman, MD
• Organization: University of Colorado Anschutz Medical Campus

adnin.zaman@cuanschutz.edu

5852761001

Study Officials

• Adnin Zaman, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 29, 2021
• Study Start: May 23, 2022
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-12

Locations

US (2)