Safety,Effectiveness and Acceptability of Sino-implant II in DR
NCT ID: NCT01594632
Last Updated: 2017-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
650 participants
INTERVENTIONAL
2011-01-31
2017-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Jadelle
Contraception using Jadelle implant
Jadelle
LNG containing subdermal contraceptive implant
Sino-implant (II)
levonorgestrel containing subdermal contraceptive implant \[Zarin, Femplant, Trust or Simplant\]
Sino-implant (II)
LNG containing subdermal contraceptive implant
Interventions
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Jadelle
LNG containing subdermal contraceptive implant
Sino-implant (II)
LNG containing subdermal contraceptive implant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
44 Years
FEMALE
Yes
Sponsors
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Bill and Melinda Gates Foundation
OTHER
FHI 360
OTHER
Responsible Party
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Principal Investigators
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Vivian Brache, LIC
Role: PRINCIPAL_INVESTIGATOR
Profamilia
Locations
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Profamilia
Santo Domingo, , Dominican Republic
Countries
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Other Identifiers
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10242
Identifier Type: -
Identifier Source: org_study_id