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

NCT01594632 | Completed DMC

• 1 other identifier: 10242
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contraception

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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

• 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

Study Arms (2)

Jadelle

EXPERIMENTAL

Contraception using Jadelle implant

Drug: Jadelle

Sino-implant (II)

ACTIVE COMPARATOR

levonorgestrel containing subdermal contraceptive implant \[Zarin, Femplant, Trust or Simplant\]

Drug: Sino-implant (II)

Interventions

Jadelle DRUG

LNG containing subdermal contraceptive implant

Jadelle

Sino-implant (II) DRUG

LNG containing subdermal contraceptive implant

Also known as: Zarin, Femplant, Trust, Simplant

Sino-implant (II)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• FHI 360: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Profamilia

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Vivian Brache, LIC

  Profamilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: May 9, 2012
• Study Start: January 1, 2011
• Primary Completion: July 4, 2017
• Study Completion: July 4, 2017
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

DO (1)