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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594632
• Other study ID #: 10242
• 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
• 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)

Related Conditions & MeSH terms

• Contraception

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