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Physiological, psychological and behavioural effects of long-acting reversible contraception

Physiological, psychological and behavioural effects of long-acting reversible contraception

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201706001651380
Enrollment
648
Registered
2016-05-25
Start date
2016-05-26
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression ,Sexual Dysfunction, menstrual disturbances

Interventions

IM injection of DMPA (medroxyprogesterone acetate sterile aqueous suspension 150 mg per 1 mL)
Levonorgestrel (LNG) Implant
Copper IUD (Paragard-T 380A®, Duramed)

Sponsors

South African Medical Research Council
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: be eligible for the study a woman must meet all of the following criteria: ¿ 18-35 years of age ¿ HIV-seronegative ¿ Wants to use effective contraception ¿ Is able and willing to provide written informed consent ¿ Agrees to be randomised to either DMPA, NET-En, or copper IUD ¿ Agrees to use assigned method for 18 months ¿ Agrees to follow all study requirements ¿ Intends to stay in the study area for the next 18 months, and willing and able to provide adequate locator information ¿ If recently pregnant, is at least 6 weeks post-partum ¿ Is sexually active (has had vaginal sex within the last 3 months) or was pregnant within the last 3 months ¿ Agrees not to participate in studies of drugs or vaccines or any other clinical research study while participating in this study.

Exclusion criteria

Exclusion criteria: ¿ Reported medical contraindications (WHO MEC Category 3 or 4) to copper IUDs, NET-En, or DMPA, including: o recent septic abortion o suspicious unexplained vaginal bleeding o breast, cervical, uterine, or ovarian cancer o high BP or heart disease, venous thromboembolism, stroke, or diabetes o liver disease or liver tumours o use of liver enzyme inducing medications (see appendix 9) ¿ Is found to have pelvic tuberculosis or uterine fibroids with distortion of the uterine cavity on pelvic exam ¿ Has untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhoea or chlamydia ¿ Has used DMPA, Net-En, or an IUD in the last 6 months ¿ Is pregnant or intending to become pregnant in the next 18 months ¿ Has had a hysterectomy or sterilization ¿ Has previously participated in the study ¿ Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation

Design outcomes

Primary

MeasureTime frame
1.Depression

Countries

South Africa

Contacts

Public ContactMandisa Singata-Madliki

Co-Director, ECRU

mandisa.singata@gmail.com+27 43 7092709

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026