NCT01594632CompletedNot Applicable
A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- FHI 360
- Enrollment
- 650
- Locations
- 1
- Primary Endpoint
- Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Jadelle
Experimental
Contraception using Jadelle implant
Intervention: Jadelle (Drug)
Sino-implant (II)
Active Comparator
levonorgestrel containing subdermal contraceptive implant [Zarin, Femplant, Trust or Simplant]
Intervention: Sino-implant (II) (Drug)
Outcomes
Primary Outcomes
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
- Evaluate the contraceptive effectiveness of Sino-implant (II) during 5 years of use(5 years)
- Compare concentrations of levonorgestrel through 5 years after insertion of Sino-implant (II) and Jadelle(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.(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(5 years)
- Compare the safety and acceptability of Sino-implant (II) and Jadelle during 5 years of use(5 years)
Investigators
Study Sites (1)
Loading locations...
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