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

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Drug: Jadelle; Drug: Sino-implant (II)

• Registration Number: NCT01594632
• Lead Sponsor: FHI 360

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-09
• Primary Completion: 2017-07-04
• Study Completion: 2017-07-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 650

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jadelle	Jadelle	Contraception using Jadelle implant
Sino-implant (II)	Sino-implant (II)	levonorgestrel containing subdermal contraceptive implant \[Zarin, Femplant, Trust or Simplant\]

Primary Outcome Measures

Name	Time	Method
Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use.	4 years	Pearl Index (number of pregnancies per 100 woman-years) over 4 years of use of Sino-implant (II).

Secondary Outcome Measures

Name	Time	Method
Evaluate the contraceptive effectiveness of Sino-implant (II) during 5 years of use	5 years	Pearl Index over 5 years of use of Sino-implant (II) ; continuation \& reasons for discontinuation in both groups.
Compare concentrations of levonorgestrel through 5 years after insertion of Sino-implant (II) and Jadelle	5 years	annual and cumulative probability of pregnancy during 5 years of use of Sino-implant (II);
Compare free levonorgestrel index through 5 years after insertion of Sino-implant (II) and Jadelle in a sub-group of approximately 150 users.	5 years	free levonorgestrel index, estimated as the ratio of levonorgestrel to sex hormone binding globulin at various point during 5 years of product use in a sub-group of approximately 150 women.
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	5 years	The PK profile of LNG during the first 6 months post-insertion including the following parameters in a sub-group of users undergoing intensive LNG sampling: Mean LNG concentrations at 6 hours, 24 hours, 48 hours, 72 hours, 7 days and 90 days post-insertion Concentration-time profiles of LNG (individual and pooled) Maximal concentration (Cmax) and time to maximal concentration (Tmax) AUC0-7 days, AUC0-1mon, AUC0-3mon and AUC0-6mon
Compare the safety and acceptability of Sino-implant (II) and Jadelle during 5 years of use	5 years	Adverse event rates in both treatment groups Annual and cumulative probability of early discontinuation in both treatment groups Reasons for discontinuation in both treatment groups Responses on acceptability questionnaires in both treatment groups

Trial Locations

Locations (1)

Profamilia; 🇩🇴 Santo Domingo, Dominican Republic