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

NCT05041699 | Completed Phase 1 FDA Drug

• 1 other identifier: IPM 056/CCN019B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations

Conditions

Pharmacokinetics; Safety Issues; Bleeding

Outcome Measures

Primary Outcomes (2)

• Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in plasma

  DPV and LNG concentrations in plasma

  90 days (3 cycles, one cycle is approximately 30 days of continuous use)

• Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in cervicovaginal fluid

  DPV and LNG concentrations in cervicovaginal fluid

  90 days (3 cycles, one cycle is approximately 30 days of continuous use)

Secondary Outcomes (4)

• The safety of two DPV-LNG vaginal ring formulations

  90 days

• Assessing vaginal bleeding patterns associated with the two DPV-LNG vaginal ring formulations

  90 days

• Frequency of study vaginal ring removal (voluntary and involuntary)

  90 days (3 cycles, one cycle is approximately 30 days of continuous use)

• Duration of study vaginal ring removal

  90 days (3 cycles, one cycle is approximately 30 days of continuous use)

Study Arms (2)

IPM Ring-105

EXPERIMENTAL

Ring-105 (xx mg dapivirine + xxx mg levonorgestrel)

Combination Product: IPM Ring-105

IPM Ring-106.

ACTIVE COMPARATOR

Ring-106 (xx mg dapivirine + xxx mg levonorgestrel)

Combination Product: IPM Ring-106

Interventions

IPM Ring-105 COMBINATION_PRODUCT

DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel

IPM Ring-105

IPM Ring-106 COMBINATION_PRODUCT

DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel

IPM Ring-106.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 within 90 days prior to Enrollment
• Age 18 through 45 years (inclusive) at Screening
• Able and willing to provide written informed consent to be screened for and enrolled in the CCN019B study
• Able and willing to provide adequate locator/contact information
• Able to communicate in spoken and written English
• Available for all visits and able and willing to comply with all study procedures and requirements
• Willing to abstain from insertion of anything into the vagina (including receptive intercourse, tampons) for 24 hours preceding the Enrollment Visit and clinical visits where samples are taken
• Not at risk for pregnancy due to use of an effective nonhormonal method of contraception or practice per participant report at Enrollment, and intending to continue use of an effective, non-hormonal method for the duration of study participation. Effective methods and practices are defined as:
• Non-hormonal (e.g. copper) intrauterine device (IUD) inserted at least 90 days prior to Enrollment
• Consistent and correct male condom use\*
• \*Details regarding this criterion will be specified in the IPM 056/CCN019B Study Manual
• Sterilization (of participant or partner)
• Having sex exclusively with individuals assigned female sex at birth
• Sexually abstinent for 90 days prior to Enrollment, and intending to remain abstinent for the duration of study participation
• Permanent contraception

You may not qualify if:

• BMI greater than 40 kg/m2 at Screening visit
• Diagnosed with symptomatic urinary tract infection (UTI) or reproductive tract infection (RTI) at Screening or Enrollment visits. Otherwise eligible participants diagnosed with symptomatic UTI/RTI during screening will be offered treatment. If treatment is complete and symptoms have resolved within the 90-day screening window, eligible participants may be enrolled.
• Participant report and/or clinical evidence of any of the following:
• Known adverse reaction to any component of the study product (ever)
• Chronic and/or recurrent vaginal candidiasis and/or recurrent symptomatic bacterial vaginosis
• Has a contraindication to a progestin-only contraceptive method as defined by a category 3 or 4 condition according to the CDC US Medical Eligibility Criteria for Contraceptive Use, 201652
• Use of hormonal contraception, including hormonal IUD and implants within the 28 days prior to the Enrollment Visit.
• Current use or planned use of strong CYP3A inhibitors and inducers. A full list of CYP3A inhibitors and inducers can be found here: http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm#4
• Current use or planned use of antibiotics and/or corticosteroids that may interact with levonorgestrel
• Non-therapeutic injection drug use in the 12 months prior to Enrollment
• Post-exposure prophylaxis (PEP) for HIV exposure within the 3 months prior to Enrollment
• Pre-exposure prophylaxis (PrEP) for HIV prevention within the 3 months prior to Enrollment
• Last pregnancy outcome less than 60 days prior to Enrollment
• Currently breastfeeding or planning to breastfeed during the study period
• Any Grade 2 or higher laboratory abnormalities and any of the following Grade 1 laboratory abnormalities at the Screening Visit+:

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• International Partnership for Microbicides, Inc.: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

UPMC Magee-Womens Hospital, Center for Family Planning Research

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Steytler, MBChB

  IPM SA NPC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 13, 2021
• Study Start: June 20, 2022
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)