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Completed

NCT Number: NCT01594632

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

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

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Key information

Conditions

Contraception Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Profamilia

Santo Domingo, Dominican Republic

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Jadelle

Drug

LNG containing subdermal contraceptive implant

Sino-implant (II)

Drug

LNG containing subdermal contraceptive implant

Other names: Zarin, Femplant, Trust, Simplant

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
May 9, 2012
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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