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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01594632
Other study ID # 10242
Secondary ID
Status Completed
Phase N/A
First received October 13, 2011
Last updated September 19, 2017
Start date January 2011
Est. completion date July 4, 2017

Study information

Verified date September 2017
Source FHI 360
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 650
Est. completion date July 4, 2017
Est. primary completion date July 4, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 44 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Jadelle
LNG containing subdermal contraceptive implant
Sino-implant (II)
LNG containing subdermal contraceptive implant

Locations

Country Name City State
Dominican Republic Profamilia Santo Domingo

Sponsors (2)

Lead Sponsor Collaborator
FHI 360 Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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