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

A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II

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

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Jadelle; Drug: 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 Type: Interventional
• Enrollment (Actual): 650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Profamilia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jadelle; Contraception using Jadelle implant	Drug: Jadelle; LNG containing subdermal contraceptive implant
Active Comparator: Sino-implant (II); levonorgestrel containing subdermal contraceptive implant [Zarin, Femplant, Trust or Simplant]	Drug: Sino-implant (II); LNG containing subdermal contraceptive implant; Other Names: Zarin, Femplant, Trust, Simplant

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the contraceptive effectiveness of Sino-implant (II) during 5 years of use	Pearl Index over 5 years of use of Sino-implant (II) ; continuation & reasons for discontinuation in both groups.	5 years
Compare concentrations of levonorgestrel through 5 years after insertion of Sino-implant (II) and Jadelle	annual and cumulative probability of pregnancy during 5 years of use of Sino-implant (II);	5 years
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	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	5 years
Compare the safety and acceptability of Sino-implant (II) and Jadelle during 5 years of use	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	5 years
Compare free levonorgestrel index through 5 years after insertion of Sino-implant (II) and Jadelle in a sub-group of approximately 150 users.	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.	5 years

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Vivian Brache, LIC, Profamilia

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 4, 2017
• Study Completion (Actual): July 4, 2017

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• 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; 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; ICH International Conference of Harmonization
• Other Study ID Numbers: 10242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided