Clinical trial NCT01594632: Safety,Effectiveness and Acceptability of Sino-implant II in DR
Official title: A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: AE adverse event
AIDS acquired immunodeficiency syndrome
ALT (SGPT) alanine aminotransferase
ART antiretroviral therapy
AST (SGOT) aspartate aminotransferase
DCF data collection forms
DMC Data Monitoring Committee
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
HB sAg Hepatitis B surface antigen
ICH International Conference of Harmonization
IND Investigational New Drug Application
IRB Institutional Review Board
IU International units
mg milligram(s)
mm3 cubic millimeter(s)
PCR polymerase chain reaction
SAE serious adverse event
µg microgram
ULN upper limit of the normal range
WB Western Blot
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2012-05-09
Enrollment: 650
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use.
timeFrame: 4 years
Secondary outcomes:
measure: Evaluate the contraceptive effectiveness of Sino-implant (II) during 5 years of use
timeFrame: 5 years
measure: Compare concentrations of levonorgestrel through 5 years after insertion of Sino-implant (II) and Jadelle
timeFrame: 5 years
measure: Compare pharmacokinetic profiles of Sino-implant (II) and Jadelle during the first 6 months of use in a sub-group of users undergoing intensive levonorgestrel sampling
timeFrame: 5 years
measure: Compare the safety and acceptability of Sino-implant (II) and Jadelle during 5 years of use
timeFrame: 5 years
measure: Compare free levonorgestrel index through 5 years after insertion of Sino-implant (II) and Jadelle in a sub-group of approximately 150 users.
timeFrame: 5 years
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Profamilia
Study officials:
affiliation: Profamilia
name: Vivian Brache, LIC
role: PRINCIPAL_INVESTIGATOR
References: