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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594632
First Posted: May 9, 2012
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
FHI 360
October 13, 2011
May 9, 2012
September 21, 2017
January 2011
July 4, 2017   (Final data collection date for primary outcome measure)
Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use. [ Time Frame: 4 years ]
Pearl Index (number of pregnancies per 100 woman-years) over 4 years of use of Sino-implant (II).
Pearl Index over 4 years of use of Sino-implant (II) [ Time Frame: 4 years ]
Complete list of historical versions of study NCT01594632 on ClinicalTrials.gov Archive Site
  • Evaluate the contraceptive effectiveness of Sino-implant (II) during 5 years of use [ Time Frame: 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 [ Time Frame: 5 years ]
    annual and cumulative probability of pregnancy during 5 years of use of Sino-implant (II);
  • 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 [ Time Frame: 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 [ Time Frame: 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
  • Compare free levonorgestrel index through 5 years after insertion of Sino-implant (II) and Jadelle in a sub-group of approximately 150 users. [ Time Frame: 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.
  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ]
    Pearl Index over 5 years of use of Sino-implant (II) ; continuation & reasons for discontinuation in both groups.
  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ]
    annual and cumulative probability of pregnancy during 5 years of use of Sino-implant (II)
  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ]
    levonorgestrel concentrations measured by HPLC/MS
  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ]
    LNG concentrations and estimated PK parameters during the first 6 months of use in a sub-group of users; adverse events
Not Provided
Not Provided
 
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).
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Contraception
  • Drug: Jadelle
    LNG containing subdermal contraceptive implant
  • Drug: Sino-implant (II)
    LNG containing subdermal contraceptive implant
    Other Name: Zarin, Femplant, Trust, Simplant
  • Experimental: Jadelle
    Contraception using Jadelle implant
    Intervention: Drug: Jadelle
  • Active Comparator: Sino-implant (II)
    levonorgestrel containing subdermal contraceptive implant [Zarin, Femplant, Trust or Simplant]
    Intervention: Drug: Sino-implant (II)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
July 4, 2017
July 4, 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 44 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Dominican Republic
 
 
NCT01594632
10242
Yes
Not Provided
Plan to Share IPD: Undecided
FHI 360
FHI 360
Bill and Melinda Gates Foundation
Principal Investigator: Vivian Brache, LIC Profamilia
FHI 360
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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