Post-randomization Differences in Condomless Vaginal Sex Among Women Randomized to Intramuscular Depot Medroxyprogesterone Acetate Injections, a Copper Intrauterine Device or a Levonorgestrel Implant in the ECHO Trial

Deese, Jennifer; Chen, Pai Lien; Gao, Xiaoming; Heffron, Renee; Hobbs, Marcia M.; Lapple, Dana; Jaspan, Heather B.; Miller, Ashley; Nair, Gonasagrie; Onono, Maricianah; Palanee‐Phillips, Thesla; Reddy, Krishnaveni; Steiner, Markus J.

doi:10.1007/s10461-022-03834-y

Cited by 4 publications

(6 citation statements)

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“…In addition, the recall data are consistent with objective data on semen exposure from an ancillary study at three of the ECHO sites. Prostate-specific antigen levels in cervical samples were less frequent in a sample of women allocated to DMPA-IM than to the Cu-IUD, and significantly less than the implant [ 19 ].…”

Section: Discussionmentioning

confidence: 99%

Sexual behaviour among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Data from the ECHO randomized trial

Hofmeyr,

Singata-Madliki,

Batting

et al. 2024

PLoS ONE

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Background Contraceptive use has complex effects on sexual behaviour and mood, including those related to reduced concerns about unintended pregnancy, direct hormonal effects and effects on endogenous sex hormones. We set out to obtain robust evidence on the relative effects of three contraceptive methods on sex behaviours, which is important for guiding contraceptive choice and future contraceptive developments. Methods This is a secondary analysis of data from the Evidence for Contraceptive Options and HIV Outcomes (ECHO) randomized trial in which 7,829 HIV-uninfected women from 12 sites in Eswatini, Kenya, South Africa and Zambia seeking contraception were randomly assigned to intramuscular depot-medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (Cu-IUD) or the levonorgestrel (LNG) implant. Data collected for 12 to 18 months using 3-monthly behavioural questionnaires that relied on recall from the preceding 3 months, were used to estimate relative risk of post-baseline sex behaviours, as well as sexual desire and menstrual bleeding between randomized groups using modified Poisson regression. Results We observed small but generally consistent effects wherein DMPA-IM users reported lower prevalence of specified high risk sexual behaviours than implant users than Cu-IUD users (the ‘>‘ and ‘<‘ symbols indicate statistically significant differences): multiple sex partners 3.6% < 4.8% < 6.2% respectively; new sex partner 3.0% < 4.0% <5.3%; coital acts 16.45, 16.65, 17.12 (DMPA-IM < Cu-IUD); unprotected sex 65% < 68%, 70%; unprotected sex past 7 days 33% <36%, 37%; sex during vaginal bleeding 7.1%, 7.1% < 8.9%; no sex acts 4.1%, 3.8%, 3.4% (DMPA-IM > Cu-IUD); partner has sex with others 10% < 11%, 11%. The one exception was having any sex partner 96.5%, 96.9% < 97.4% (DMPA-IM < Cu-IUD). Decrease in sexual desire was reported by 1.6% > 1.1% >0.5%; amenorrhoea by 49% > 41% >12% and regular menstrual pattern by 26% <35% < 87% respectively. Conclusions These findings suggest that women assigned to DMPA-IM may have a modest decrease in libido and sexual activity relative to the implant, and the implant relative to the Cu-IUD. We found more menstrual disturbance with DMPA-IM than with the implant (and as expected, both more than the Cu-IUD). These findings are important for informing the contraceptive choices of women and policymakers and highlight the need for robust comparison of the effects of other contraceptive methods as well.

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Section: Discussionmentioning

confidence: 99%

Sexual behaviour among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Data from the ECHO randomized trial

Hofmeyr,

Singata-Madliki,

Batting

et al. 2024

PLoS ONE

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“… 92 . Additionally, T. vaginalis was significantly more prevalent among Cu‐IUD users than DMPA‐IM or LNG‐implant users at 18 months, although the baseline prevalence across the arms is unknown 93 . This may be due to the evidence of less condomless sex in the DMPA‐IM arm 94 .…”

Section: Impact Of Contraceptives On the Vaginal Microbial Communitymentioning

confidence: 99%

“…N. gonorrhoeae prevalence was also lower in the DMPA-IM arm compared to the LNG-implant arm, albeit not significantly so.. 92 Additionally, T. vaginalis was significantly more prevalent among Cu-IUD users than DMPA-IM or LNG-implant users at 18 months, although the baseline prevalence across the arms is unknown. 93 This may be due to the evidence of less condomless sex in the DMPA-IM arm. 94 In the UChoose cohort, lower N. gonorrhoea incidence but a higher incidence of M. genitalium was found in adolescents after 16 weeks of NET-EN use compared to adolescents randomly assigned to the ETG/EE IVR and OCP arms.…”

Section: Randomized Datamentioning

confidence: 99%

“…93 This may be due to the evidence of less condomless sex in the DMPA-IM arm. 94 In the UChoose cohort, lower N. gonorrhoea incidence but a higher incidence of M. genitalium was found in adolescents after 16 weeks of NET-EN use compared to adolescents randomly assigned to the ETG/EE IVR and OCP arms. 80 Furthermore, the incidence of any bacterial STI was found to be higher in adolescents using ETG/EE IVR compared to those using NET-EN or OCP.…”

Section: Randomized Datamentioning

confidence: 99%

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Contraceptive effects on the cervicovaginal microbiome: Recent evidence including randomized trials

Balle,

Happel,

Heffron

et al. 2023

American J Rep Immunol

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BackgroundUntil recently, most data regarding the effects of non‐barrier contraceptives on the mucosal microbiome have derived from observational studies, which are potentially biased due to behavioral confounders that may mask their true biological effects.Method of StudyThis narrative review summarises recent evidence of the effect of contraceptives on the cervicovaginal microbiome, emphasising data obtained through randomized trials.ResultsGood quality data describe that initiation of long‐acting progestin‐only contraceptives, including levonorgestrel (LNG)‐implant and the injectables depot‐medroxyprogesterone acetate (DMPA‐IM) and norethisterone enanthate (NET‐EN) do not alter the mucosal microbial environment. Likewise, no strong evidence exists that the use of oral contraceptive pills (OCPs) is associated with alterations of the vaginal microbiome or increased risk of bacterial sexually transmitted infections (STIs). Limited data on the effect of intravaginal rings (IVRs) on the mucosal environment exist and show conflicting effects on the vaginal microbiota. Copper intrauterine device (Cu‐IUD) initiation has been associated with bacterial vaginosis (BV) acquisition, including in a randomized trial. LNG‐IUDs may have similar affects but need to be evaluated further.ConclusionDifferent synthetic hormones have divergent effects on the microbiome and therefore novel hormonal methods need to be rigorously evaluated. Furthermore, the addition of antiretrovirals into multipurpose technologies may alter the effects of the hormonal component. There is thus a critical need to improve our understanding of the biological effects of contraceptive hormones and delivery methods with different pharmacokinetic and chemical properties on the mucosal microbiome in rigorous trials, to inform the development of novel contraceptives and improve individual family planning guidance.

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“…After oral administration, it can regulate the level of progesterone in the patient's body, thereby resisting the long-term action of estrogen on the endometrium and regulating uterine function. As a progestogen drug, medroxyprogesterone is often used in dysfunctional uterine bleeding, CE, endometriosis, endometrial cancer and other conditions such as shedding, proliferation and menstrual repair [10] .…”

Section: Groupmentioning

confidence: 99%

Clinical Efficacy of Medroxyprogesterone Combined with Different Antibiotics in the Treatment of Chronic Endometritis

Li,

Wang

2023

IJPS

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The objective of this study was to determine the clinical value of medroxyprogesterone combined with different antibiotics in the treatment of chronic endometritis. A total of 320 subjects were selected and divided into study group and control group according to odd and even numbers, with 160 subjects in each group. The control group was treated with combination of antibiotics and the research group was given medroxyprogesterone on the basis of the control group. The medication cycle is 5 d. A comparative study was carried out on the effects of medication between the two groups. After medication, the total effective rate of patients in the study group was 94.37 %, significantly higher than 75.63 % in the control group (p<0.05). The levels of inflammation in both groups were reduced, but the research group was significantly better than the control group (p<0.05). The endometrial thickness and uterine recovery time in the study group were significantly better than those in the control group (p<0.05), while the sex hormone levels and irregular vaginal bleeding rate in the study group were significantly lower than those in the control group (p<0.05). The normal rate of menstruation and quality of life scores in the study group were significantly higher than those in the control group (p<0.05), and there was no significant difference in adverse drug reactions between the two groups (p>0.05). Progesterone combined with different antibiotics has a significant effect on chronic endometritis, which can reduce the level of inflammation, increase the thickness of endometrium, improve the level of uterine status and normal menstruation rate, reduce the level of sex hormones and the rate of irregular vaginal bleeding, etc. It has a good effect, high drug safety, helps to improve the quality of life and is worthy of popularization.

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Post-randomization Differences in Condomless Vaginal Sex Among Women Randomized to Intramuscular Depot Medroxyprogesterone Acetate Injections, a Copper Intrauterine Device or a Levonorgestrel Implant in the ECHO Trial

Cited by 4 publications

References 6 publications

Sexual behaviour among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Data from the ECHO randomized trial

Sexual behaviour among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Data from the ECHO randomized trial

Contraceptive effects on the cervicovaginal microbiome: Recent evidence including randomized trials

Clinical Efficacy of Medroxyprogesterone Combined with Different Antibiotics in the Treatment of Chronic Endometritis

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