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Trial record 60 of 403 for:    LEVONORGESTREL

PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel

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ClinicalTrials.gov Identifier: NCT03467347
Recruitment Status : Completed
First Posted : March 16, 2018
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Tracking Information
First Submitted Date  ICMJE March 9, 2018
First Posted Date  ICMJE March 16, 2018
Last Update Posted Date October 9, 2019
Actual Study Start Date  ICMJE July 17, 2018
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in plasma. [ Time Frame: 90 days ]
  • Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in cervicovaginal fluid. [ Time Frame: 90 days ]
  • Evaluate pharmacokinetics by assessing changes in baseline of DPV concentration in cervical tissue. [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03467347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • Incidence of Grade 2 or higher genitourinary adverse events as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected V 2.1,or Addendum 1 Female Genital Grading Table for Use in Microbicide Studies [ Time Frame: 90 days ]
  • Incidence of Grade 3 or higher adverse events as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
Official Title  ICMJE A Randomized, Phase 1, Open-Label Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety and Bleeding Patterns Associated With 90-Day Use of Matrix Vaginal Rings Containing 200 mg Dapivirine and 320 mg Levonorgestrel
Brief Summary This is a Phase I single-center, two-arm, open-label, randomized study in healthy HIV-negative women to evaluate the pharmacokinetics, safety, and bleeding patterns associated with 90-day use of matrix vaginal rings containing 200 mg Dapivirine and 320 mg Levonorgestrel.
Detailed Description

This 26 week study will be conducted at one site. The site will enroll 24 subjects. Subjects will be randomized to 1 of 2 treatment regimens:

Regimen A: vaginal ring used continuously for approximately 90 days Regimen B: vaginal ring used cyclically for approximately 90 days: used for ~28 days, then removed,washed and stored for 2 days. The same ring will be used for 2 additional cycles in a similar fashion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Healthy
  • Contraception
  • Contraceptive Usage
  • Women
Intervention  ICMJE Drug: VR: 200 mg DPV + 320 mg LNG
One silicone elastomer vaginal ring (VR) containing the active ingredients dapivirine (DPV) and levonorgestrel (LNG), formulated as IPM VR: 200 mg DPV + 320 mg LNG (Ring-102)
Study Arms  ICMJE
  • Experimental: VR used continuously for approximately 90 days
    One silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used continuously for approximately 90 days.
    Intervention: Drug: VR: 200 mg DPV + 320 mg LNG
  • Experimental: VR used cyclically for approximately 90 days
    One silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used cyclically for approximately 90 days. Use the VR for 28 days, remove for 2 days.
    Intervention: Drug: VR: 200 mg DPV + 320 mg LNG
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: June 12, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2018)
24
Actual Study Completion Date  ICMJE October 7, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Assigned female sex at birth Note: Participants who are female at birth, who now identify as male, will not be excluded so long as they are not currently or have not been on female-to-male transition therapy 90 days prior to Enrollment.
  2. Age 18 through 45 years (inclusive) at Screening, verified per site SOPs
  3. Able and willing to provide written informed consent to be screened for and enrolled in MTN-044/IPM 053/CCN019
  4. Able and willing to provide adequate locator information, as defined in site SOPs
  5. Able to communicate in spoken and written English
  6. Available for all visits and able and willing to comply with all study procedural requirements
  7. Willing to abstain from receptive intercourse (vaginal, oral, sex toy/vibrator/dildo and finger stimulation) and tampon use for 24 hours preceding the Enrollment Visit and clinical visits where samples are taken and for 1 week following each cervical biopsy visit
  8. Not at risk for pregnancy, defined as consistently using an effective, non-hormonal method of contraception per participant report at Enrollment, and intending to continue use of an effective, non-hormonal method for the duration of study participation. Effective methods include:

    1. Non-hormonal (e.g. copper) intrauterine device (IUD) inserted at least 28 days prior to Enrollment
    2. Consistent and correct male condom use
    3. Sterilization (of participant or partner, as defined in site SOPs)
    4. Having sex exclusively with individuals assigned female sex at birth
    5. Sexually abstinent for 90 days prior to Enrollment, and intending to remain abstinent for the duration of study participation
  9. In general good health as determined by the Investigator of Record (IoR)/designee at Screening and Enrollment
  10. HIV-uninfected based on testing performed at Screening and Enrollment
  11. Per participant report at Screening, current regular menstrual cycles of approximately 21 to 35 days in duration with no reported intermenstrual bleeding
  12. Intact uterus with at least one ovary
  13. Per participant report at Screening and Enrollment, states a willingness to refrain from inserting any non-study vaginal products or objects into the vagina including, but not limited to spermicides, female condoms, diaphragms, other intravaginal rings, vaginal medications, menstrual cups, cervical caps (or any other vaginally applied barrier method), vaginal douches, lubricants and moisturizers, for the 24 hours preceding the Enrollment Visit through completion of Visit 15.
  14. Participants over the age of 21 (inclusive) must have documentation of a satisfactory Pap within the past 3 years prior to Enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result
  15. At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products or vaccines after the Screening Visit through completion of Visit 15

Exclusion Criteria:

  1. Body mass index greater than 40 kg/m2 at Screening
  2. Pregnant at Screening or Enrollment or plans to become pregnant during the study period Note: A documented negative pregnancy test performed by study staff is required for inclusion; however, a self-reported pregnancy is adequate for exclusion from the study.
  3. Diagnosed with symptomatic urinary tract infection (UTI) or reproductive tract infection (RTI) at Screening or Enrollment
  4. Diagnosed with an acute STI requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment/) at Screening or Enrollment such as gonorrhea (GC), chlamydia, trichomonas, pelvic inflammatory disease (PID), and/or syphilis Note: Genital warts requiring treatment and frequent recurrence of herpes simplex virus (HSV) are considered exclusionary; however, infrequent HSV outbreaks are not. Genital warts requiring treatment are defined as those that cause undue burden or discomfort to the participant, including bulky size, unacceptable appearance, or physical discomfort.
  5. Has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff) at Screening or Enrollment, as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007]) Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary.
  6. Participant report and/or clinical evidence of any of the following:

    1. Known adverse reaction to any component of the study product (ever)
    2. Chronic and/or recurrent vaginal candidiasis
    3. Has a contraindication to a progestin-only contraceptive method as defined by a category 3 or 4 condition according to the CDC U.S. Medical Eligibility Criteria for Contraceptive Use, 201643
    4. Use of hormonal contraception, including hormonal IUD and implants within the 28 days prior to Enrollment
    5. Current use or planned use of CYP3A inhibitors and inducers
    6. Current use or planned use of antibiotics and/or corticosteroids that may interact with levonorgestrel
    7. Depot medroxyprogesterone acetate (DMPA) use in the 6 months prior to Enrollment or any prior use without return of regular spontaneous menstrual cycles.
    8. Non-therapeutic injection drug use in the 12 months prior to Enrollment
    9. Post-exposure prophylaxis (PEP) for HIV exposure within the 3 months prior to Enrollment
    10. Pre-exposure prophylaxis (PrEP) for HIV prevention within the 3 months prior to Enrollment
    11. Last pregnancy outcome less than 60 days prior to Enrollment
    12. Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) 45 days or less prior to Enrollment Note: Pap test at the Screening Visit, colposcopy and cervical biopsies for evaluation of an abnormal Pap test as well as IUD insertion/removal are not exclusionary.
    13. Currently breastfeeding or planning to breastfeed during the study period
    14. Participation in any other research study involving drugs, medical devices, vaginal products or vaccines, in the 60 days prior to Enrollment
  7. Has any of the following Grade 1 or higher laboratory abnormalities at Screening Visit:

    1. AST or ALT
    2. Creatinine
    3. Hemoglobin
  8. Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objectives including any significant uncontrolled active or chronic medical condition.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
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 NCT03467347
Other Study ID Numbers  ICMJE MTN-044/IPM 053/CCN019
5UM1AI068633 ( U.S. NIH Grant/Contract )
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 Not Provided
Responsible Party International Partnership for Microbicides, Inc.
Study Sponsor  ICMJE International Partnership for Microbicides, Inc.
Collaborators  ICMJE
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Division of AIDS, US National Institute of Allergy and Infectious Diseases
  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE Not Provided
PRS Account International Partnership for Microbicides, Inc.
Verification Date October 2019

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