Safety,Effectiveness and Acceptability of Sino-implant II in DR (NCT01594632) | Clinical Trial Compass
CompletedNot Applicable
Safety,Effectiveness and Acceptability of Sino-implant II in DR
Dominican Republic650 participantsStarted 2011-01
Plain-language summary
A study to assess the contraceptive effectiveness of Sino-implant (II).
Who can participate
Age range18 Years – 44 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 h…
What they're measuring
1
Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use.