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

A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II

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

Randomized trial to assess the contraceptive effectiveness of Sino-implant (II) and to compare levonorgestrel concentrations, safety and acceptability of Sino-implant (II) and Jadelle.

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)