Safety,Effectiveness and Acceptability of Sino-implant II in DR

• Status: Completed
• Trial end date: 2017-07-04
• Target enrollment: 0
• Participant gender: Female

Summary

A study to assess the contraceptive effectiveness of Sino-implant (II).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Collaborator: Bill and Melinda Gates Foundation
• Treatments: Contraceptive Agents; Levonorgestrel

Criteria

Inclusion Criteria:• In good general health

• Aged between 18 and 44 years, inclusive

• Not pregnant

• Not lactating

• Not wishing to become pregnant in the next five years

• Request long-acting reversible contraception

• If previously used injectable contraceptives for pregnancy prevention, be more than 9 months since last injection of Depo-Provera and more than 3 months after the last injection of a combined injectable contraceptive

• If previously used LNG-containing oral pills or implants, be more than 1 week after last hormone intake or implant removal

• Be able to understand the information provided and to make personal decisions on participation

• Consent to participation and sign a consent form

• Agree and be able to return to the clinic for follow-up visits over five years

Exclusion Criteria:

• acute deep venous thrombosis and/or pulmonary embolism or history of thromboembolic disease

• systemic lupus erythematosus with positive or unknown antiphospholipid antibodies

• unexplained vaginal bleeding

• current or history of breast cancer

• acute liver disease or cirrhosis

• benign or malignant tumor of the liver

• use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing St. John's Wort (Hypericum perforatum)

• more than one sexual partner in the last 3 months

• diagnosis or treatment for a sexually transmitted infection (STI) within the past 30 days for her or partner (excluding recurrent genital herpes or condyloma)

• known HIV positive status for her or partner

• any condition (social or medical) which in the opinion of the Investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation

• BMI greater than or equal to 30 (for the sub-group of women with intensive LNG sampling)