SafetyEarly Phase 1MATRIX-003NCT06163274
Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings
A Early Phase 1 study of Safety and Acceptability, run by University of Pittsburgh at 5 sites in 3 countries.
Trial summary
This research study is being conducted to find out how easy, comfortable, and safe intravaginal rings are for women to use. The two rings used in this study do not dispense any medications, are the same size, but differ in their flexibility and hardness. 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
- Safety, Acceptability
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 28 Feb 2024to 24 Jan 2025
- Phase
- Early 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.
- Able and willing to provide written informed consent to be screened for and enrolled in MATRIX-003 in one of the study languages.
- Able and willing to provide adequate contact/locator information.
- Able and willing to comply with all protocol requirements, including:
- Abstaining from other intravaginal products or practices for the duration of the study.
- Abstaining from penetrative vaginal intercourse (i.e., oral-, digital-, penile-penetration) for the first 14 days of each product use period.
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- Refraining from participation in other research studies involving drugs, medical devices, vaginal products, or vaccines starting 2 weeks before the Screening Visit and for the duration of the study, or in observational or qualitative studies for the duration of the study, unless approved by the Protocol Safety Review Team.
- Reliable access to a private phone for scheduled phone contacts.
- HIV-uninfected based on testing performed at Screening and Enrollment.
- Per participant report, must be either not currently sexually active or in a mutually monogamous relationship with only one partner who is not known to be HIV positive or to currently have a sexually transmitted infection.
- Negative urine pregnancy test at Screening and Enrollment.
- Participants over the age of 21 (inclusive) must have documentation of a Grade 0 Pap smear within the past 3 years prior to Enrollment, or a Grade 1 Pap smear at Screening with no treatment required.
- Protected from pregnancy starting at least 2 weeks before Screening and continuing for the duration of study participation by an effective contraceptive method; effective methods include:
- Hormonal methods except vaginal rings
- Copper intrauterine device
- Sterilization of participant or (if applicable) sterilization of monogamous partner
- Correct and consistent condom use at study entry, and agrees to use site-provided condoms during study (for US site only)
- Inclusion Criteria for sexual partner in-depth interview subset:
- Identifies as a sexual partner of a MATRIX-003 participant.
- Identified by participant as a sexual partner during MATRIX-003 for whom the participant has given permission to contact.
- Able and willing to provide written informed consent in one of the study languages.
- Able and willing to complete the required study procedures.
- Must be 18 years old or above at the time of their study participation.
Who cannot join
- Per participant report at Screening and Enrollment, intends to do any of the following during the study participation period:
- Become pregnant.
- Breastfeed.
- Relocate away from the study site.
- Travel away from the study site for a time period that would interfere with product resupply and/or study participation.
- Positive HIV test at Screening or Enrollment.
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- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or Treponema pallidum (Syphilis) at Screening and (per participant report) treated for potential sexually transmitted infection within past 12 months.
- Diagnosed with urinary tract infection, pelvic inflammatory disease, or reproductive tract infection requiring treatment at Enrollment.
- Note: Otherwise eligible participants diagnosed during screening with a urinary tract infection, symptomatic yeast infection or symptomatic bacterial vaginosis infection are offered treatment. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled.
- Clinically apparent Grade 2 or higher pelvic exam finding at Enrollment.
- Note: Otherwise eligible participants with exclusionary pelvic exam findings at Screening may be enrolled/randomized if treatment is completed at least 7 days prior to enrollment and findings have improved to a non-exclusionary severity grading or resolved by the time of enrollment. Spotting/bleeding will be considered exclusionary only if greater than what would be expected from contraceptive use.
- Participant report and/or clinical evidence of any of the following:
- Known adverse reaction to silicone (ever).
- Use of diaphragm, NuvaRing, or spermicide for contraception starting 2 weeks prior to Screening through Enrollment.
- Use of any of the following in the past 12 months: stimulants (cocaine [including crack], methamphetamine, or non-physician prescribed pharmaceutical-grade stimulants), or inhaled nitrates, or illicit injection drug use of any kind.
- Prior use of post-exposure prophylaxis or oral pre-exposure prophylaxis (including Emtricitabine/tenofovir) in the past 4 weeks or any prior use of long-acting systemic pre-exposure prophylaxis (including cabotegravir or islatravir).
- Antibiotic, steroid, or antifungal (oral or intravaginal) therapy within 14 days of Enrollment.
- Hysterectomy.
- Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing, Intrauterine device insertion or removal, colposcopy) within 21 days prior to Enrollment.
- At Screening or Enrollment, as determined by the Investigator of Record/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease.
- Has any of the following laboratory abnormalities at Screening:
- Grade 2 or higher Aspartate aminotransferase, alanine transaminase, creatinine, or Hemoglobin.
- Has any other condition that, in the opinion of the Investigator of Record/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
South Africa3 sites
Wits Reproductive Health and HIV Institute
Hillbrow, Johannesburg, 2038
Centre for the AIDS Programme of Research in South Africa - Vululindlela
Pietermaritzburg, KwaZulu-Natal, 3291
The Aurum Institue - Tembisa #4
Tembisa, 1632
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: MATRIX-003: Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Ring Designs
This research study is being conducted to find out how easy, comfortable, and safe intravaginal rings are for women to use. The two rings used in this study do not dispense any medications, are the same size, but differ in their flexibility and hardness. This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, South Africa, and Zimbabwe. Participants will be randomly assigned to use (self-insert) Ring A for 4 weeks and then Ring B for 4 weeks or Ring B first followed by Ring A. There will be a 1-3-week rest period between using the two different rings. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples over a total of 7 in-person visits and 2 telephone calls over approximately 9-11 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in-depth interviews to further assess acceptability, attitudes, and experiences with ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.
Read the detailed description
The goal of this randomized, clinical trial is to compare two placebo intravaginal rings in HIV seronegative persons, aged 18-45 years, assigned female sex at birth who are at low risk of acquiring HIV infection. Participants will be recruited from five sites, one in the US and four in sub-Saharan Africa. Approximately 100 participants will be randomized (1:1), stratified by site, to the sequence of using the two intravaginal rings (A followed by B or B followed by A). The two rings differ only by mechanical attributes, such as flexibility and hardness. Each ring will be self-inserted and left in place for 4-weeks. After 4 weeks, the first assigned ring will be removed by the participant at the clinic. Then there will be a 7-21-day period of no ring use. The participant will then return to the clinic and self-insert the second assigned ring and leave it in place for 4 weeks, after which the participant will return to the clinic for self-removal of the ring. Differences in safety, acceptability, social harms and benefits, and composition of the vaginal microbiome between the two rings will be assessed. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in-depth interviews to further assess acceptability, attitudes, and experiences with ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.
- Conditions
- Safety, Acceptability
- Being tested
- Placebo Intravaginal Ring A, Placebo Intravaginal Ring B
- Keywords
- Vagina, Placebo, Intravaginal Ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Intravaginal Ring ADevice
Placebo Intravaginal Ring A consists of a flexible lavender silicone scaffold, with an outer diameter of 55 mm and a durometer value of 40A (Shore A hardness scale). The ring holds two blank grey cassettes.
Placebo Intravaginal Ring BDevice
Placebo Intravaginal Ring B consists of a flexible lavender silicone scaffold, with an outer diameter of 55 mm and a durometer value of 50A (Shore A hardness scale). The ring holds two blank grey cassettes.
| Study group | Role | What they receive |
|---|---|---|
| Sequence: Placebo Intravaginal Ring A followed by Placebo Intravaginal Ring B | Experimental | Placebo Intravaginal Ring A will be inserted and used for 28 days, Ring A will be removed and followed by no intravaginal ring use for 7-21 days. Then Placebo Intravaginal Ring B will be inserted and used for 28 days. Receives: Device: Placebo Intravaginal Ring A; Device: Placebo Intravaginal Ring B |
| Sequence: Placebo Intravaginal Ring B followed by Placebo Intravaginal Ring A | Experimental | Placebo Intravaginal Ring B will be inserted and used for 28 days, Ring B will be removed and followed by no intravaginal ring use for 7-21 days. Then Placebo Intravaginal Ring A will be inserted and used for 28 days. Receives: Device: Placebo Intravaginal Ring A; Device: Placebo Intravaginal Ring B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Preferring to Use Placebo Intravaginal Ring A versus Ring B
Number of participants that report a preference to use placebo intravaginal Ring A versus Ring B
Measured: Through study completion, approximately 11 weeks
Mean Satisfaction with Placebo Intravaginal Ring Use
Satisfaction will be assessed using a 10-point Likert scale with 0 being the least satisfied and 10 being the most satisfied
Measured: Through study completion, approximately 11 weeks
Secondary outcomes (1)
Number of Participants with Genitourinary Grade 2 or Higher Adverse Events
Number of participants with genitourinary Grade 2 or higher adverse events deemed related to placebo intravaginal ring use
Measured: Through study completion, approximately 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start28 Feb 2024
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Why it stopped: Due to Stop Work order issued on1/24/2025 as result of United States President's Executive Order on Reevaluating and Realigning United States Foreign Aid
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will randomized to sequence of using 2 placebo intravaginal rings; Ring A followed by Ring B or Ring B followed by Ring A
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Oak Crest Institute of Science
- Responsible party
- Principal investigator, Catherine Anne Chappell, University of Pittsburgh
- Investigators
- Catherine A Chappell, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163274
- Sponsor's protocol ID
- STUDY23070172
- Acronym
- MATRIX-003
- Status last verified
- Feb 2025
- First submitted
- 30 Nov 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palanee-Phillips T, Baum MM, Moss JA, Clark MR, Nuttall J, Romano JW. Drug-releasing vaginal rings for HIV/STI and pregnancy prevention: a review of recent advances and clinical applications. Expert Opin Drug Deliv. 2022 Jan;19(1):47-58. doi: 10.1080/17425247.2022.2020242. Epub 2022 Jan 7.
PubMed 34958283Ridgeway K, Montgomery ET, Smith K, Torjesen K, van der Straten A, Achilles SL, Griffin JB. Vaginal ring acceptability: A systematic review and meta-analysis of vaginal ring experiences from around the world. Contraception. 2022 Feb;106:16-33. doi: 10.1016/j.contraception.2021.10.001. Epub 2021 Oct 10.
PubMed 34644609Stoner MCD, Browne EN, Gundacker HM, Hawley I, Chen BA, Hoesley C, Scheckter R, Piper J, Singh D, Song M, Liu A, van der Straten A. Acceptability of an extended duration vaginal ring for HIV prevention and interest in a multi-purpose ring. PLoS One. 2022 Feb 22;17(2):e0263664. doi: 10.1371/journal.pone.0263664. eCollection 2022.
PubMed 35192655Minnis AM, Etima J, Musara P, Browne EN, Mutero P, Kemigisha D, Mgodi NM, Nakabiito C, Shapley-Quinn MK, Stoner MCD, Hartmann M, Macagna N, Piper J, van der Straten A. Couples' Preferences for "2 in 1" Multipurpose Prevention Technologies to Prevent Both HIV and Pregnancy: Results of a Discrete Choice Experiment in Uganda and Zimbabwe. AIDS Behav. 2022 Dec;26(12):3848-3861. doi: 10.1007/s10461-022-03713-6.
PubMed 35674885
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MATRIX-003: Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Ring Designs
- ClinicalTrials.gov ID
- NCT06163274
- Acronym / sponsor ID
- MATRIX-003 / STUDY23070172
- Conditions
- Safety, Acceptability
- Keywords
- Vagina, Placebo, Intravaginal Ring
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Stop Work order issued on1/24/2025 as result of United States President's Executive Order on Reevaluating and Realigning United States Foreign Aid
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Oak Crest Institute of Science
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 8 Dec 2023 (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 research study is being conducted to find out how easy, comfortable, and safe intravaginal rings are for women to use. The two rings used in this study do not dispense any medications, are the same size, but differ in their flexibility and hardness. This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, South Africa, and Zimbabwe. Participants will be randomly assigned to use (self-insert) Ring A for 4 weeks and then Ring B for 4 weeks or Ring B first followed by Ring A. There will be a 1-3-week rest period between using the two different rings. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples over a total of 7 in-person visits and 2 telephone calls over approximately 9-11 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in-depth interviews to further assess acceptability, attitudes, and experiences with ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.
Detailed description
The goal of this randomized, clinical trial is to compare two placebo intravaginal rings in HIV seronegative persons, aged 18-45 years, assigned female sex at birth who are at low risk of acquiring HIV infection. Participants will be recruited from five sites, one in the US and four in sub-Saharan Africa. Approximately 100 participants will be randomized (1:1), stratified by site, to the sequence of using the two intravaginal rings (A followed by B or B followed by A). The two rings differ only by mechanical attributes, such as flexibility and hardness. Each ring will be self-inserted and left in place for 4-weeks. After 4 weeks, the first assigned ring will be removed by the participant at the clinic. Then there will be a 7-21-day period of no ring use. The participant will then return to the clinic and self-insert the second assigned ring and leave it in place for 4 weeks, after which the participant will return to the clinic for self-removal of the ring. Differences in safety, acceptability, social harms and benefits, and composition of the vaginal microbiome between the two rings will be assessed. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in-depth interviews to further assess acceptability, attitudes, and experiences with ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will randomized to sequence of using 2 placebo intravaginal rings; Ring A followed by Ring B or Ring B followed by Ring A
| Arm | Type | Receives |
|---|---|---|
| Sequence: Placebo Intravaginal Ring A followed by Placebo Intravaginal Ring B | Experimental | Device: Placebo Intravaginal Ring A, Device: Placebo Intravaginal Ring BPlacebo Intravaginal Ring A will be inserted and used for 28 days, Ring A will be removed and followed by no intravaginal ring use for 7-21 days. Then Placebo Intravaginal Ring B will be inserted and used for 28 days. |
| Sequence: Placebo Intravaginal Ring B followed by Placebo Intravaginal Ring A | Experimental | Device: Placebo Intravaginal Ring A, Device: Placebo Intravaginal Ring BPlacebo Intravaginal Ring B will be inserted and used for 28 days, Ring B will be removed and followed by no intravaginal ring use for 7-21 days. Then Placebo Intravaginal Ring A will be inserted and used for 28 days. |
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.
- Able and willing to provide written informed consent to be screened for and enrolled in MATRIX-003 in one of the study languages.
- Able and willing to provide adequate contact/locator information.
- Able and willing to comply with all protocol requirements, including:
- HIV-uninfected based on testing performed at Screening and Enrollment.
Key exclusion criteria (23 listed)
- Per participant report at Screening and Enrollment, intends to do any of the following during the study participation period:
- Positive HIV test at Screening or Enrollment.
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or Treponema pallidum (Syphilis) at Screening and (per participant report) treated for potential sexually transmitted infection within past 12 months.
- Diagnosed with urinary tract infection, pelvic inflammatory disease, or reproductive tract infection requiring treatment at Enrollment.
- Note: Otherwise eligible participants diagnosed during screening with a urinary tract infection, symptomatic yeast infection or symptomatic bacterial vaginosis infection are offered treatment. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled.
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 |
|---|---|---|
| Placebo Intravaginal Ring APlacebo Intravaginal Ring A consists of a flexible lavender silicone scaffold, with an outer diameter of 55 mm and a durometer value of 40A (Shore A hardness scale). The ring holds two blank grey cassettes. | Device | Sequence: Placebo Intravaginal Ring A followed by Placebo Intravaginal Ring B, Sequence: Placebo Intravaginal Ring B followed by Placebo Intravaginal Ring A |
| Placebo Intravaginal Ring BPlacebo Intravaginal Ring B consists of a flexible lavender silicone scaffold, with an outer diameter of 55 mm and a durometer value of 50A (Shore A hardness scale). The ring holds two blank grey cassettes. | Device | Sequence: Placebo Intravaginal Ring A followed by Placebo Intravaginal Ring B, Sequence: Placebo Intravaginal Ring B followed by Placebo Intravaginal Ring A |
Primary outcome
Number of Participants Preferring to Use Placebo Intravaginal Ring A versus Ring B
Time frame: Through study completion, approximately 11 weeks
Number of participants that report a preference to use placebo intravaginal Ring A versus Ring B
Mean Satisfaction with Placebo Intravaginal Ring Use
Time frame: Through study completion, approximately 11 weeks
Satisfaction will be assessed using a 10-point Likert scale with 0 being the least satisfied and 10 being the most satisfied
1 secondary outcome
Number of Participants with Genitourinary Grade 2 or Higher Adverse Events
Time frame: Through study completion, approximately 11 weeks
Results and safety
The study was stopped early (reason given: Due to Stop Work order issued on1/24/2025 as result of United States President's Executive Order on Reevaluating and Realigning United States Foreign Aid). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 34958283Palanee-Phillips T, Baum MM, Moss JA, Clark MR, Nuttall J, Romano JW. Drug-releasing vaginal rings for HIV/STI and pregnancy prevention: a review of recent advances and clinical applications. Expert Opin Drug Deliv. 2022 Jan;19(1):47-58. doi: 10.1080/17425247.2022.2020242. Epub 2022 Jan 7.
- Background: PubMed 34644609Ridgeway K, Montgomery ET, Smith K, Torjesen K, van der Straten A, Achilles SL, Griffin JB. Vaginal ring acceptability: A systematic review and meta-analysis of vaginal ring experiences from around the world. Contraception. 2022 Feb;106:16-33. doi: 10.1016/j.contraception.2021.10.001. Epub 2021 Oct 10.
- Background: PubMed 35192655Stoner MCD, Browne EN, Gundacker HM, Hawley I, Chen BA, Hoesley C, Scheckter R, Piper J, Singh D, Song M, Liu A, van der Straten A. Acceptability of an extended duration vaginal ring for HIV prevention and interest in a multi-purpose ring. PLoS One. 2022 Feb 22;17(2):e0263664. doi: 10.1371/journal.pone.0263664. eCollection 2022.
- Background: PubMed 35674885Minnis AM, Etima J, Musara P, Browne EN, Mutero P, Kemigisha D, Mgodi NM, Nakabiito C, Shapley-Quinn MK, Stoner MCD, Hartmann M, Macagna N, Piper J, van der Straten A. Couples' Preferences for "2 in 1" Multipurpose Prevention Technologies to Prevent Both HIV and Pregnancy: Results of a Discrete Choice Experiment in Uganda and Zimbabwe. AIDS Behav. 2022 Dec;26(12):3848-3861. doi: 10.1007/s10461-022-03713-6.
- 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.
Catherine A Chappell, MD principal investigator
University of Pittsburgh
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Safety and Acceptability, run by University of Pittsburgh at 5 sites in 3 countries.
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 23 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: stopped early, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa, United States, Zimbabwe. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Due to Stop Work order issued on1/24/2025 as result of United States President's Executive Order on Reevaluating and Realigning United States Foreign Aid). Results are not available in the source record.
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?
Number of Participants Preferring to Use Placebo Intravaginal Ring A versus Ring B (time frame: Through study completion, approximately 11 weeks). 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?
On the ClinicalTrials.gov record for NCT06163274, which also lists 4 linked publications.
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 3 Mar 2025.