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Trial record 17 of 405 for:    LEVONORGESTREL

PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel (DAP/LNG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02855346
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Tracking Information
First Submitted Date  ICMJE June 21, 2016
First Posted Date  ICMJE August 4, 2016
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE May 3, 2017
Actual Primary Completion Date August 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
Dapivirine and levonorgestrel concentrations in blood and Vaginal fluid [ Time Frame: 14 days ]
To characterize the local and systemic pharmacokinetics of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Dapivirine and levonorgestrel concentrations in blood and Vaginal fluid [ Time Frame: 14 days ]
To characterize the local and systemic pharmacokinetics of one dapivirine vaginal ring formulation and two dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days
Change History Complete list of historical versions of study NCT02855346 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
Grade 2 or higher Genitourinary adverse event and Grade 3 or higher adverse event as defined by DAIDS [ Time Frame: 14 days ]
To evaluate the safety of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Grade 2 or higher Genitourinary adverse event and Grade 3 or higher adverse event as defined by DAIDS [ Time Frame: 14 days ]
To evaluate the safety of one dapivirine vaginal ring formulation and two dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel
Official Title  ICMJE A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel Vaginal Rings
Brief Summary PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel
Detailed Description A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Prevention
Intervention  ICMJE
  • Combination Product: 200 mg of DPV + 320 mg LNG
    DPV VR, containing 200 mg DPV
    Other Name: Dapivirine
  • Combination Product: 200 mg of DPV
    DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG
    Other Name: Dapivirine/Levonorgestrel
Study Arms  ICMJE
  • Experimental: 200 mg of DPV
    Each participant will receive a VR containing either 200 mg DPV or 200 mg DPV + 320 mg LNG. Participants will be randomized in a 1:1 ratio. The VR should be worn for approximately 14 consecutive days +/-1 day. The ring will be removed by the participant (or clinician/designee, if necessary) at the Product Use End Visit (PUEV)/Early Termination Visit. The participant will be followed for approximately 2 days following VR removal
    Intervention: Combination Product: 200 mg of DPV + 320 mg LNG
  • Experimental: 200 mg of DPV + 320 mg LNG
    Each participant will receive a VR containing either 200 mg DPV or 200 mg DPV + 320 mg LNG. Participants will be randomized in a 1:1 ratio. The VR should be worn for approximately 14 consecutive days +/-1 day. The ring will be removed by the participant (or clinician/designee, if necessary) at the Product Use End Visit (PUEV)/Early Termination Visit. The participant will be followed for approximately 2 days following VR removal
    Intervention: Combination Product: 200 mg of DPV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
36
Actual Study Completion Date  ICMJE August 18, 2017
Actual Primary Completion Date August 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy women

Exclusion Criteria:

  • HIV infected women
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02855346
Other Study ID Numbers  ICMJE MTN-030/IPM 041
5UM1 A1068633 ( Other Grant/Funding Number: Division of AIDS, US National Institute of Allergy and Infectious Diseases US Eunice Kennedy Shriver National Institute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party International Partnership for Microbicides, Inc.
Study Sponsor  ICMJE International Partnership for Microbicides, Inc.
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account International Partnership for Microbicides, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP