PACTR201706001651380
Recruiting
N/A
Physiological, psychological and behavioural effects of long-acting reversible contraception
South African Medical Research Council0 sites648 target enrollmentMay 25, 2016
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Depression ,Sexual Dysfunction, menstrual disturbances
- Sponsor
- South African Medical Research Council
- Enrollment
- 648
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Exclusion Criteria
- •¿Reported medical contraindications (WHO MEC Category 3 or 4\) to copper IUDs, NET\-En, or DMPA, including:
- •orecent septic abortion
- •osuspicious unexplained vaginal bleeding
- •obreast, cervical, uterine, or ovarian cancer
- •ohigh BP or heart disease, venous thromboembolism, stroke, or diabetes
- •oliver disease or liver tumours
- •ouse 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
Outcomes
Primary Outcomes
Not specified
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