PharmacokineticsPhase 1NCT05041699
PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
A Phase 1 study testing IPM Ring-105 and IPM Ring-106 in people with Pharmacokinetics and Safety Issues, run by International Partnership for Microbicides, Inc. at 2 sites in United States.
Trial summary
A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Safety Issues, Bleeding
- What is being tested?
- IPM Ring-105 and IPM Ring-106
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jun 2022to 7 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
- In general, good health as determined by the Investigator of Record (IoR)/designee at Screening and Enrollment visits
- HIV-uninfected based on testing performed at the Screening and Enrollment visits
- Per participant report at Screening, current regular menstrual cycles of approximately 21 to 35 days in duration with no reported intermenstrual bleeding or heavy menstrual bleeding per discussion with the Investigator.
- Intact uterus with at least one ovary
- Per participant report at Screening and Enrollment visits, states a willingness to refrain from inserting any non-study vaginal products or objects into the vagina from the Enrollment Visit through completion of the in-person PK follow-up visits with the exception of tampon use and intercourse, which can occur but not within 24 hours of the study visit.
- Documentation of a satisfactory Pap test within ASCCP or ACOG guidelines such that additional treatment will not be required during the study period. If a copy of a Pap test (and indicated follow-up testing) is not available and the subject is 21 years or older, a Pap test should be done during the screening period.
- Subjects must be ovulatory as confirmed by a documented screening progesterone (P4) level ≥ 3 ng/mL by local laboratory.
- At Screening and Enrollment visits, agrees not to participate in other research studies involving drugs, medical devices, vaginal products or vaccines after the Screening Visit through completion of participation on the trial.
Who cannot join
- BMI greater than 40 kg/m2 at Screening visit
- Pregnant at Screening or Enrollment visits 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.
- 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.
- Diagnosed with an acute STI requiring treatment per current CDC guidelines (http://www.cdc.gov/std/treatment/) at Screening or Enrollment visits such as gonorrhea (GC), chlamydia, trichomonas, and/or pelvic inflammatory disease (PID) Note: Genital warts requiring treatment and greater than two disease flares of herpes simplex virus (HSV) within a year 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. See IPM 056/CCN019B Study Manual for additional information.
- 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.
- Note: Otherwise eligible participants with exclusionary pelvic exam findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved within 90 days of providing informed consent for screening.
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- 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
- 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.
- 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+:
- AST*
- ALT*
- Creatinine*
- Hemoglobin*
- Platelet count* Note: Otherwise eligible participants with an exclusionary laboratory result may be re-tested and may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved within 90 days of providing informed consent for screening. Results of safety laboratory testing performed at the Enrollment Visit are expected to be received after the Enrollment Visit, and thus will not be exclusionary. Abnormal results will be noted as pre-existing conditions, and may result in product discontinuation, per IoR discretion as per Section 7.2.1 of the protocol.
- 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])53 +This DAIDS table can be found in the SPM
- 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.
- Be a site staff member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member with delegated study responsibilities.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Magee-Womens Hospital, Center for Family Planning Research
Pittsburgh, Pennsylvania, 15213-3180
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated With 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel
A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations
Read the detailed description
A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated with 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel
- Conditions
- Pharmacokinetics, Safety Issues, Bleeding
- Being tested
- IPM Ring-105, IPM Ring-106
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPM Ring-105Combination product
DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel
IPM Ring-106Combination product
DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel
| Study group | Role | What they receive |
|---|---|---|
| IPM Ring-105 | Experimental | Ring-105 (xx mg dapivirine + xxx mg levonorgestrel) Receives: Combination Product: IPM Ring-105 |
| IPM Ring-106. | Active comparator | Ring-106 (xx mg dapivirine + xxx mg levonorgestrel) Receives: Combination Product: IPM Ring-106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in plasma
DPV and LNG concentrations in plasma
Measured: 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
Measured: 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
Incidence of Grade 2, grade 3 or higher genitourinary adverse events as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected v2.1 July 2017, or Addendum 1 Female Genital Grading Table for Use in Microbicide Studies
Measured: 90 days
Assessing vaginal bleeding patterns associated with the two DPV-LNG vaginal ring formulations
Total number of days bleeding/spotting by participant self-report in a diary card
Measured: 90 days
Frequency of study vaginal ring removal (voluntary and involuntary)
Self-reported attitudes about ring attributes, use regimens and tolerability by completing an acceptability questionnaire. Residual drug levels (DPV and LNG) in returned vaginal rings
Measured: 90 days (3 cycles, one cycle is approximately 30 days of continuous use)
Duration of study vaginal ring removal
Self-reported attitudes about ring attributes, use regimens and tolerability by completing an acceptability questionnaire. Residual drug levels (DPV and LNG) in returned vaginal rings
Measured: 90 days (3 cycles, one cycle is approximately 30 days of continuous use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start20 Jun 2022
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- John Steytler, MBChB, Study chair, IPM SA NPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041699
- Sponsor's protocol ID
- IPM 056/CCN019B
- Status last verified
- Mar 2026
- First submitted
- 24 Aug 2021
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated With 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel
- ClinicalTrials.gov ID
- NCT05041699
- Acronym / sponsor ID
- IPM 056/CCN019B
- Conditions
- Pharmacokinetics, Safety Issues, Bleeding
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations
Detailed description
A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated with 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPM Ring-105 | Experimental | Combination Product: IPM Ring-105Ring-105 (xx mg dapivirine + xxx mg levonorgestrel) |
| IPM Ring-106. | Active comparator | Combination Product: IPM Ring-106Ring-106 (xx mg dapivirine + xxx mg levonorgestrel) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (28 listed)
- BMI greater than 40 kg/m2 at Screening visit
- Pregnant at Screening or Enrollment visits 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.
- 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.
- Diagnosed with an acute STI requiring treatment per current CDC guidelines (http://www.cdc.gov/std/treatment/) at Screening or Enrollment visits such as gonorrhea (GC), chlamydia, trichomonas, and/or pelvic inflammatory disease (PID) Note: Genital warts requiring treatment and greater than two disease flares of herpes simplex virus (HSV) within a year 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. See IPM 056/CCN019B Study Manual for additional information.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPM Ring-105DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel | Combination product | IPM Ring-105 |
| IPM Ring-106DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel | Combination product | IPM Ring-106. |
Primary outcome
Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in plasma
Time frame: 90 days (3 cycles, one cycle is approximately 30 days of continuous use)
DPV and LNG concentrations in plasma
Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in cervicovaginal fluid
Time frame: 90 days (3 cycles, one cycle is approximately 30 days of continuous use)
DPV and LNG concentrations in cervicovaginal fluid
4 secondary outcomes
The safety of two DPV-LNG vaginal ring formulations
Time frame: 90 days
Assessing vaginal bleeding patterns associated with the two DPV-LNG vaginal ring formulations
Time frame: 90 days
Frequency of study vaginal ring removal (voluntary and involuntary)
Time frame: 90 days (3 cycles, one cycle is approximately 30 days of continuous use)
Duration of study vaginal ring removal
Time frame: 90 days (3 cycles, one cycle is approximately 30 days of continuous use)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Steytler, MBChB study chair
IPM SA NPC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPM Ring-105 and IPM Ring-106 in people with Pharmacokinetics and Safety Issues, run by International Partnership for Microbicides, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in plasma (time frame: 90 days (3 cycles, one cycle is approximately 30 days of continuous use)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.