Evidence map›Paper›PMID 38459552›Full record

Trial reportBMC women's health2024

Effects of depot medroxyprogesterone acetate, the copper IUD and the levonorgestrel implant on testosterone, sex hormone binding globulin and free testosterone levels: ancillary study of the ECHO randomized clinical trial.

G Justus Hofmeyr, Mandisa Singata-Madliki, Joanne Batting, Yusentha Balakrishna, Chelsea Morroni

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMC women's health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02550067 (A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women Using Depot Medroxyprogesterone Acetate), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
6.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02550067 nacompletednot on this map

A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women Using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)

TypeinterventionalSponsorFHI 360Ran2015 to 2018Enrolled7,830ConditionsHIV, ContraceptionArmsDMPA, LNG, Copper IUD
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 3 countries.

G Justus HofmeyrDepartment of Obstetrics and Gynaecology, University of Botswana, Notwane Rd, Gaborone, Botswana. justhof@gmail.com.ORCID 0000-0002-3080-1007
Mandisa Singata-MadlikiEffective Care Research Unit, University of Fort Hare, Church St, East London, South Africa.ORCID 0000-0003-4193-8786
Joanne BattingEffective Care Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
Yusentha BalakrishnaBiostatistics Research Unit, South African Medical Research Council, Durban, South Africa.ORCID 0000-0001-6449-3260
Chelsea MorroniBotswana Harvard AIDS Institute Partnership, Gaborone, Botswana.ORCID 0000-0002-2026-6039
South African Medical Research Council · ZAMRC Centre for Reproductive Health · GBUniversity of Fort Hare · ZAWestern Cape Department of Health · ZA

Funding

Bill & Melinda Gates Foundation OPP1032115
6 · The paper itself

Abstract

backgroundRobust information on relative effects of hormonal contraceptives on endogenous androgens is important for understanding beneficial and adverse effects, method choice and development of new methods.

methodsIn this ancillary study at the East London, South Africa site of the ECHO multicentre randomized trial, we compared effects of three contraceptive methods on serum androgen levels among contraceptive users aged 18 to 35 years. Participants were allocated by centrally-managed randomization to open label depot medroxyprogesterone acetate (DMPA-IM), copper intrauterine device (IUD) or levonorgestrel implant. The primary outcome was free testosterone at 6 months.

resultsWe analysed stored baseline and 6-month serum samples in 398/615 participants (DMPA-IM 131/205, IUD 135/205 and implant 132/205). Median testosterone levels at baseline were DMPA-IM 0.82, IUD 0.9 and implant 0.87 nmol/L; at 6 months, DMPA 0.68 (lower than IUD, mean percentage difference 28.35, (p <  0.001), IUD 0.86 (unchanged) and implant 0.66, lower than IUD, mean percentage difference - 22.98, p <  0.001). Median SHBG levels at baseline were DMPA 52.4, IUD 50.5 and implant 55.75 nmol/L; at 6 months, DMPA 40.65, lower than IUD (mean percentage difference 21.19, p = 0.005), IUD 49.1 (unchanged), and implant 23.35 nmol/L, lower than IUD (mean percentage difference - 50.04, p <  0.001 and than DMPA (mean percentage difference - 39.45, p <  0.001). Free testosterone levels at baseline were DMPA 10, IUD 12 and implant 11 pmol/L; at 6 months, DMPA 11, less than IUD (mean percentage difference 13.53, p = 0.047), IUD 12 and implant 14, higher than IUD (mean percentage difference 14.15, p = 0.038) and than DMPA, (mean percentage difference 29.60, p <  0.001).

conclusionsThis is the first randomized trial to show lower SHBG and higher free testosterone with the levonorgestrel implant than with DMPA, and contrasts with reports of increased SHBG with combined oral ethinyl estradiol/levonorgestrel use, and reduced androgens (and impaired sexual function) reported with the etonorgestrel implant. The higher free testosterone with the LNG implant might improve sexual function, mood and bone health as well as increasing side-effects such as acne and hirsutism, and is consistent with the greater sexual activity (with respect to multiple sex partners, new sex partner and unprotected sex) with the implant compared with DMPA documented in the ECHO study. ECHO

trial registrationClinicalTrials.gov , number NCT02550067 15/09/2015. Contraception, or family planning, is central to the role of women in societies. It is most important to have accurate information on the relative side-effects of various contraceptive options in order to empower women to make informed choices regarding their preferred method. Hormonal contraceptives contain various forms of the female sex hormones, estrogens and/or progestogens. These hormones have direct effects on the users, as well as modifying the levels of the users' own circulating sex hormones, both the 'female' and the 'male' sex hormones (androgens). In this study, consenting participants requesting contraception, were allocated randomly to receive either depot medroxyprogesterone acetate (DMPA-IM) a 3-monthly progestogen injection, the copper intrauterine device (IUD), a non-hormonal contraceptive inserted within the womb, or the levonorgestrel implant, a device placed under the skin which releases a progestogen for 5 years. We measured the participants' androgen levels after 6 months, and found for the first time that the active form of testosterone (free testosterone) was 29% higher with the implant than with DMPA-IM. The level with the IUD was intermediate, and significantly different from the other two methods. This finding is relevant to the effects experienced by users of these methods, because free testosterone has effects on sexual function, bone health and mood, as well as on conditions such as acne and hair distribution patterns.

Indexed as

Acne VulgarisContraceptive Agents, FemaleIntrauterine Devices, CopperAdolescentAdultAndrogensFemaleHumansLevonorgestrelMedroxyprogesterone AcetateProgestinsSex Hormone-Binding GlobulinTestosteroneYoung AdultAndrogensContraceptive Agents, FemaleLevonorgestrelMedroxyprogesterone AcetateProgestinsSex Hormone-Binding GlobulinTestosteroneContraceptionCopper intrauterine deviceDepot medroxyprogesterone acetateFree testosteroneLevonorgestrel implantRandomized trialSex hormone binding globulinTestosterone

Identifiers

PMID38459552
PMCPMC10921651
OpenAlexW4392591197

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.