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

Not Applicable

Recruiting

• Conditions: Depression ,Sexual Dysfunction, menstrual disturbances

• Registration Number: PACTR201706001651380
• Lead Sponsor: South African Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 648

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

¿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
¿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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Depression