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

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ClinicalTrials.gov Identifier: NCT01594632
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Contraception 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II
Study Start Date : January 2011
Primary Completion Date : July 4, 2017
Study Completion Date : July 4, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Zarin, Femplant, Trust, Simplant


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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);

  3. 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


  4. 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

  5. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594632


Locations
Dominican Republic
Profamilia
Santo Domingo, Dominican Republic
Sponsors and Collaborators
FHI 360
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Vivian Brache, LIC Profamilia
More Information

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01594632     History of Changes
Other Study ID Numbers: 10242
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by FHI 360:
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

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral