HealthyPhase 1NCT03467347
PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
A Phase 1 study testing VR: 200 mg DPV + 320 mg LNG in people with Healthy and Contraception, run by International Partnership for Microbicides, Inc. at 1 site in United States.
Trial 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. 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
- Healthy, Contraception, Contraceptive Usage
- What is being tested?
- VR: 200 mg DPV + 320 mg LNG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2018to 7 Oct 2019
- 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 90 days prior to Enrollment.
- Age 18 through 45 years (inclusive) at Screening, verified per site SOPs
- Able and willing to provide written informed consent to be screened for and enrolled in MTN-044/IPM 053/CCN019
- Able and willing to provide adequate locator information, as defined in site SOPs
- Able to communicate in spoken and written English
- Available for all visits and able and willing to comply with all study procedural requirements
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- 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
- 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:
- Non-hormonal (e.g. copper) intrauterine device (IUD) inserted at least 28 days prior to Enrollment
- Consistent and correct male condom use
- Sterilization (of participant or partner, as defined in site SOPs)
- 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
- In general good health as determined by the Investigator of Record (IoR)/designee at Screening and Enrollment
- HIV-uninfected based on testing performed at Screening and Enrollment
- Per participant report at Screening, current regular menstrual cycles of approximately 21 to 35 days in duration with no reported intermenstrual bleeding
- Intact uterus with at least one ovary
- 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.
- 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
- 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
Who cannot join
- Body mass index greater than 40 kg/m2 at Screening
- 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.
- Diagnosed with symptomatic urinary tract infection (UTI) or reproductive tract infection (RTI) at Screening or Enrollment
- 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.
- 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.
- Participant report and/or clinical evidence of any of the following:
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- Known adverse reaction to any component of the study product (ever)
- Chronic and/or recurrent vaginal candidiasis
- 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
- Use of hormonal contraception, including hormonal IUD and implants within the 28 days prior to Enrollment
- Current use or planned use of CYP3A inhibitors and inducers
- Current use or planned use of antibiotics and/or corticosteroids that may interact with levonorgestrel
- Depot medroxyprogesterone acetate (DMPA) use in the 6 months prior to Enrollment or any prior use without return of regular spontaneous menstrual cycles.
- 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
- Participation in any other research study involving drugs, medical devices, vaginal products or vaccines, in the 60 days prior to Enrollment
- Has any of the following Grade 1 or higher laboratory abnormalities at Screening Visit:
- AST or ALT
- Creatinine
- Hemoglobin
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Women'S Res Inst and Foundation
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Healthy, Contraception, Contraceptive Usage, Women
- Being tested
- VR: 200 mg DPV + 320 mg LNG
- Keywords
- Healthy Women, Contraception, Vaginal Ring, dapivirine, Levonorgestrel
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR: 200 mg DPV + 320 mg LNGDrug
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 group | Role | What they receive |
|---|---|---|
| VR used continuously for approximately 90 days | Experimental | One silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used continuously for approximately 90 days. Receives: Drug: VR: 200 mg DPV + 320 mg LNG |
| VR used cyclically for approximately 90 days | Experimental | 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. Receives: Drug: VR: 200 mg DPV + 320 mg LNG |
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.
Measured: 90 days
Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in cervicovaginal fluid.
Measured: 90 days
Evaluate pharmacokinetics by assessing changes in baseline of DPV concentration in cervical tissue.
Measured: 90 days
Secondary outcomes (2)
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
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start17 Jul 2018
- Primary completion30 Aug 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 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 Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467347
- Sponsor's protocol ID
- MTN-044/IPM 053/CCN019
- Other IDs
- 5UM1AI068633
- Status last verified
- Oct 2019
- First submitted
- 9 Mar 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Friedland BA, Gundacker H, Achilles SL, Chen BA, Hoesley C, Richardson BA, Kelly CW, Piper J, Johnson S, Devlin B, Steytler J, Kleinbeck K, Dangi B, Friend C, Song M, Mensch B, van der Straten A, Jacobson C, Hendrix CW, Brown J, Blithe D, Hiller SL; MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network. Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): Implications for multipurpose prevention technology development. PLoS One. 2025 Jan 14;20(1):e0312957. doi: 10.1371/journal.pone.0312957. eCollection 2025.
PubMed 39808648
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03467347
- Acronym / sponsor ID
- MTN-044/IPM 053/CCN019
- Conditions
- Healthy, Contraception, Contraceptive Usage, Women
- Keywords
- Healthy Women, Contraception, Vaginal Ring, dapivirine, Levonorgestrel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 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 Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 16 Mar 2018 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR used continuously for approximately 90 days | Experimental | Drug: VR: 200 mg DPV + 320 mg LNGOne silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used continuously for approximately 90 days. |
| VR used cyclically for approximately 90 days | Experimental | Drug: VR: 200 mg DPV + 320 mg LNGOne 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 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 90 days prior to Enrollment.
- Age 18 through 45 years (inclusive) at Screening, verified per site SOPs
- Able and willing to provide written informed consent to be screened for and enrolled in MTN-044/IPM 053/CCN019
- Able and willing to provide adequate locator information, as defined in site SOPs
- Able to communicate in spoken and written English
Key exclusion criteria (25 listed)
- Body mass index greater than 40 kg/m2 at Screening
- 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.
- Diagnosed with symptomatic urinary tract infection (UTI) or reproductive tract infection (RTI) at Screening or Enrollment
- 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.
- 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 |
|---|---|---|
| VR: 200 mg DPV + 320 mg LNGOne 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) | Drug | VR used continuously for approximately 90 days, VR used cyclically for approximately 90 days |
Primary outcome
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
2 secondary outcomes
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
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 9 Oct 2019.
- Derived from this study: PubMed 39808648Friedland BA, Gundacker H, Achilles SL, Chen BA, Hoesley C, Richardson BA, Kelly CW, Piper J, Johnson S, Devlin B, Steytler J, Kleinbeck K, Dangi B, Friend C, Song M, Mensch B, van der Straten A, Jacobson C, Hendrix CW, Brown J, Blithe D, Hiller SL; MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network. Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): Implications for multipurpose prevention technology development. PLoS One. 2025 Jan 14;20(1):e0312957. doi: 10.1371/journal.pone.0312957. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VR: 200 mg DPV + 320 mg LNG in people with Healthy and Contraception, run by International Partnership for Microbicides, Inc. at 1 site 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 20 inclusion and 25 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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03467347, which also lists 1 linked publication.
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 9 Oct 2019.