Depression ,Sexual Dysfunction, menstrual disturbances
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| 1.Depression | — |
Countries
South Africa
Contacts
Co-Director, ECRU