Contraceptive UsageNCT05061472
A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
An observational study of Contraceptive Usage and Overweight or Obesity, run by University of Colorado, Denver at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Contraceptive Usage, Overweight or Obesity, Body Weight Changes
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 May 2022to 23 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Comprehensive Women's Health Center
Denver, Colorado, 80230
About this study
Official title: The Influence of Combined Oral Contraceptives on Weight, Body Composition, Eating Behaviors, and Appetite 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 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.
Read the detailed description
The overall objective of this feasibility pilot study is to prospectively evaluate the effects of initiating a combined estrogen and progestin oral contraceptive (COC) compared to a non-hormonal contraceptive (NHC) on body weight, body composition, eating behaviors, and appetite in pre-menopausal women with overweight or obesity. Nearly half of the 61 million U.S. women of reproductive age have overweight or obesity, placing them and their offspring at an elevated lifetime risk of adverse cardiometabolic and health outcomes. Notably, ~15-20% of reproductive-aged women use COCs. Though many women anecdotally report weight gain as a side effect of COCs, a conclusive link between COC use and weight gain has not been established. Previous studies evaluating COCs and weight change have excluded women with obesity, who may be at greater risk for contraceptive-associated weight gain. Given the widespread use of COCs, it is critical to understand the extent to which these contraceptive methods may be associated with weight gain and correlated cardiometabolic health risks in reproductive age women with established overweight or obesity.
The reproductive hormonal profile of COC users differs substantially from that of normally cycling women. A recent study of seven typical COCs found that while median exposure to synthetic estrogens across a 28-day cycle was similar to median endogenous estrogen exposure, median synthetic progestin exposure was 4-fold higher than median endogenous progesterone exposure. COCs also lead to daily spikes in serum estrogen and progestin levels, unlike the gradual increase and cyclic patterns of endogenous hormones that characterize a normal menstrual cycle. COCs may impact weight via changes in appetite and satiety due to supraphysiologic systemic levels of reproductive hormones. For example, progesterone has been shown to increase appetite and trigger binge- or emotional-eating. The principal investigator has reported that use of COCs was associated with greater weight regain over 1 year after weight loss in women with overweight and obesity enrolled in a behavioral weight loss program. However, no studies have prospectively evaluated changes in body weight, cardiometabolic risk factors, and eating behaviors in women with overweight or obesity initiating COC vs. those using NHCs.
This study's overall hypothesis is that initiation of COCs in women with overweight or obesity will be associated with greater weight gain and increases in cardiometabolic health risks than use of NHCs over 6 months. The investigators will recruit pre-menopausal women with overweight or obesity who have already elected to initiate COCs as well as a control group of age and BMI matched NHC users. The investigators will evaluate the feasibility of recruiting women initiating a COC and women using NHCs into a prospective, observational study as well as the feasibility of evaluating changes in weight, body composition, eating behaviors, and appetite over 6 months from COC initiation. The investigators propose the following specific aims:
Aim 1: Assess the feasibility of recruiting and retaining a racially/ethnically diverse group of pre-menopausal women with overweight or obesity initiating COCs compared to age- and BMI-matched NHC users. 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.
Exploratory Aim 2: Explore the influence of COC vs. NHC use on body weight, body composition, and cardiometabolic risk factors. The investigators hypothesize that women with overweight or obesity initiating COCs will exhibit greater increases in body weight, fat mass, homeostatic model assessment for insulin resistance (HOMA-IR), triglycerides, and blood pressure compared to age- and BMI-matched NHC users.
Exploratory Aim 3: Explore the influence of COC vs. NHC use on energy intake (EI), eating behaviors, and appetite. The investigators hypothesize that women with overweight or obesity initiating COCs will have greater increases in dietary energy and fat/carbohydrate intake, hunger, disinhibition, reward-based eating, emotional eating, binge eating, and food cravings at 6 months compared to age- and BMI-matched NHC users.
- 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
- Medical subject headings
- Contraception Behavior, Overweight, Obesity, Body Weight Changes, Appetitive Behavior, Feeding Behavior, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start23 May 2022
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adnin Zaman, MD, Principal investigator, University of Colorado, DenverVictoria A Catenacci, MD, Study chair, University of Colorado, DenverElizabeth A Thomas, MD, Study chair, University of Colorado, DenverAaron Lazorwitz, MD, Study chair, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061472
- Sponsor's protocol ID
- 21-3969
- Status last verified
- Dec 2024
- First submitted
- 16 Sep 2021
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27272580Cedergren 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.
PubMed 14754687Sebire 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.
PubMed 11477502Koliaki 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.
PubMed 30399375Coney 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.
PubMed 11672550Gallo 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.
PubMed 24477630Moore 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.
PubMed 8605778Redmond 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.
PubMed 10592854Risser 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.
PubMed 10401972Mayeda 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.
PubMed 24156617Gallo 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.
PubMed 14754709Grandi 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.
PubMed 24918262Lovett 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.
PubMed 28685096Fleischman 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.
PubMed 20483856Leeners 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.
PubMed 28333235
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Combined Oral Contraceptives on Weight, Body Composition, Eating Behaviors, and Appetite in Pre-menopausal Women With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT05061472
- Acronym / sponsor ID
- 21-3969
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall objective of this feasibility pilot study is to prospectively evaluate the effects of initiating a combined estrogen and progestin oral contraceptive (COC) compared to a non-hormonal contraceptive (NHC) on body weight, body composition, eating behaviors, and appetite in pre-menopausal women with overweight or obesity. Nearly half of the 61 million U.S. women of reproductive age have overweight or obesity, placing them and their offspring at an elevated lifetime risk of adverse cardiometabolic and health outcomes. Notably, ~15-20% of reproductive-aged women use COCs. Though many women anecdotally report weight gain as a side effect of COCs, a conclusive link between COC use and weight gain has not been established. Previous studies evaluating COCs and weight change have excluded women with obesity, who may be at greater risk for contraceptive-associated weight gain. Given the widespread use of COCs, it is critical to understand the extent to which these contraceptive methods may be associated with weight gain and correlated cardiometabolic health risks in reproductive age women with established overweight or obesity.
The reproductive hormonal profile of COC users differs substantially from that of normally cycling women. A recent study of seven typical COCs found that while median exposure to synthetic estrogens across a 28-day cycle was similar to median endogenous estrogen exposure, median synthetic progestin exposure was 4-fold higher than median endogenous progesterone exposure. COCs also lead to daily spikes in serum estrogen and progestin levels, unlike the gradual increase and cyclic patterns of endogenous hormones that characterize a normal menstrual cycle. COCs may impact weight via changes in appetite and satiety due to supraphysiologic systemic levels of reproductive hormones. For example, progesterone has been shown to increase appetite and trigger binge- or emotional-eating. The principal investigator has reported that use of COCs was associated with greater weight regain over 1 year after weight loss in women with overweight and obesity enrolled in a behavioral weight loss program. However, no studies have prospectively evaluated changes in body weight, cardiometabolic risk factors, and eating behaviors in women with overweight or obesity initiating COC vs. those using NHCs.
This study's overall hypothesis is that initiation of COCs in women with overweight or obesity will be associated with greater weight gain and increases in cardiometabolic health risks than use of NHCs over 6 months. The investigators will recruit pre-menopausal women with overweight or obesity who have already elected to initiate COCs as well as a control group of age and BMI matched NHC users. The investigators will evaluate the feasibility of recruiting women initiating a COC and women using NHCs into a prospective, observational study as well as the feasibility of evaluating changes in weight, body composition, eating behaviors, and appetite over 6 months from COC initiation. The investigators propose the following specific aims:
Aim 1: Assess the feasibility of recruiting and retaining a racially/ethnically diverse group of pre-menopausal women with overweight or obesity initiating COCs compared to age- and BMI-matched NHC users. 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.
Exploratory Aim 2: Explore the influence of COC vs. NHC use on body weight, body composition, and cardiometabolic risk factors. The investigators hypothesize that women with overweight or obesity initiating COCs will exhibit greater increases in body weight, fat mass, homeostatic model assessment for insulin resistance (HOMA-IR), triglycerides, and blood pressure compared to age- and BMI-matched NHC users.
Exploratory Aim 3: Explore the influence of COC vs. NHC use on energy intake (EI), eating behaviors, and appetite. The investigators hypothesize that women with overweight or obesity initiating COCs will have greater increases in dietary energy and fat/carbohydrate intake, hunger, disinhibition, reward-based eating, emotional eating, binge eating, and food cravings at 6 months compared to age- and BMI-matched NHC users.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27272580Flegal 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.
- Background: PubMed 14754687Cedergren 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.
- Background: PubMed 11477502Sebire 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.
- Background: PubMed 30399375Koliaki 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.
- Background: PubMed 11672550Coney 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.
- Background: PubMed 24477630Gallo 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.
- Background: PubMed 8605778Moore 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.
- Background: PubMed 10592854Redmond 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.
- Background: PubMed 10401972Risser 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.
- Background: PubMed 24156617Mayeda 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.
- Background: PubMed 14754709Gallo 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.
- Background: PubMed 24918262Grandi 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.
- Contraceptive Use in the United States by DemographicsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnin Zaman, MD principal investigator
University of Colorado, Denver
Victoria A Catenacci, MD study chair
University of Colorado, Denver
Elizabeth A Thomas, MD study chair
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraceptive Usage and Overweight or Obesity, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05061472, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.