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

FHI 360

Status

Completed

Conditions

Contraception

Treatments

Drug: Jadelle

Drug: Sino-implant (II)

Study type

Interventional

Funder types

Other

Identifiers

NCT01594632

10242

Details and patient eligibility

About

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

Full description

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.

Enrollment

650 patients

Sex

Female

Ages

18 to 44 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)