Weight change among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Findings from a randomised, multicentre, open-label trial.

Mags Beksinska,Katherine Thomas,Jared M Baeten,Tharnija Lalbahadur,G.Justus Hofmeyr,Thesla Palanee-Phillips,Jenni Smit,Ivana Beesham,Gonasagrie Nair,Rodal Issema,Charles Morrison,Nelly Mugo,Khatija Ahmed,Petrus S Steyn

doi:10.1016/j.eclinm.2021.100800

Abstract

BackgroundThere is limited evidence on the impact of the use of progestin-only hormonal contraception (POC) on weight change. We conducted a secondary analysis of prospective weight change among women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial.MethodsThe ECHO trial was conducted at 12 sites in eSwatini, Kenya, South Africa and Zambia between December 2015 and October 2018. HIV negative, women aged 16–35 years, desiring contraception, were randomised (1:1:1) to either 3-monthly intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel (LNG) implant or copper intrauterine device (IUD). Follow-up was up to 18 months. Weight (kg) was measured at baseline and study exit. Analysis was performed as intention to treat (ITT) and time on continuous contraceptive use. The primary outcome of this secondary analysis is weight change from study enrolment to the final visit at study month 12–18. The ECHO trial is registered with ClinicalTrials.gov, NCT02550067.Findings7829 women were randomly assigned to DMPA-IM (n = 2609), copper IUD (n = 2607) or LNG implant (n = 2613). The ITT population included 7014 women 2293 DMPA-IM group, 2372 copper IUD group and 2349 LNG group) who were not lost to follow-up, pregnant on study, or missing weight data. The mean weight increased in all groups but was significantly different in magnitude: 3.5 kg (SD = 6.3), 2.4 kg (SD = 5.9) and 1.5 kg (SD = 5.7) in the DMPA-IM, LNG implant and copper IUD groups, respectively. Comparative differences between groups were (2.02 kg (95% CI, 1.68, 2.36, p < 0.001) for DMPA-IM versus copper IUD, 0.87 kg (0.53,1.20 p < 0.001) for LNG implant compared to copper IUD and 1.16 kg (0.82, 1.50, p < 0.001) for DMPA-IM compared with LNG implant. Results for continuous contraceptive use were similar.InterpretationWe found differences in weight gain between POC users compared to the non-hormonal copper IUD group over 12–18 months of use. Women using POCs should be counselled about this potential side effect when choosing a contraceptive method.

Highlights

Progestin-only hormonal contraception (POC) is available in several forms including injectables, implants, levonorgestrel-releasing intrauterine contraception (LNG-intrauterine device (IUD)), and oral contraceptives
Women exiting at 12 months in the LNG implant and the copper IUD had gained a similar amount of weight, but in the copper IUD group those exiting at 15 and 18 months gained little or no additional weight; consistent with this observation we found that weight gain over time did not appear to be linear in the copper IUD group (p = 0.03 for nonlinear pattern of weight gain)
The Evidence for Contraceptive options and HIV Outcomes (ECHO) trial’s high retention and randomised method continuation allows our data to show true differences in both intention to treat (ITT) and continuous use analyses in weight gain between progestin-only hormonal contraception (POC) users compared to non-hormonal method users as well as differences between the two POC methods over a 12À18 month period of use

Summary

Introduction

Progestin-only hormonal contraception (POC) is available in several forms including injectables, implants, levonorgestrel-releasing intrauterine contraception (LNG-IUD), and oral contraceptives. POC use has been implicated in weight changes and weight gain is commonly cited as a side effect by users and providers [2À4], and is a frequent reason cited for method discontinuation [4À7]. Limited data are available for intrauterine and oral POCs which show small or insignificant changes in weight, in some studies an increase in fat mass was found in users of both these methods compared to non-hormonal user controls [11,16,22,24]. HIV negative, women aged 16À35 years, desiring contraception, were randomised (1:1:1) to either 3-monthly intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel (LNG) implant or copper intrauterine device (IUD). Interpretation: We found differences in weight gain between POC users compared to the non-hormonal copper IUD group over 12À18 months of use. Women using POCs should be counselled about this potential side effect when choosing a contraceptive method

Methods

Results

Conclusion