Healthy Female SubjectsNCT06740253
Safety and Acceptability Study of a Placebo Antibody-Based Nonhormonal Contraceptive Intravaginal Ring
A study of Healthy Female Subjects, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
In order to deliver nonhormonal vaginal contraceptive using anti-sperm antibodies, a new vaginal ring design using a capsule-IVR will be utilized. Evaluating the safety and acceptability of this device early in the product development cycle is important, not only because device/formulation characteristics become… 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 Female Subjects
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provide written informed consent
- Age of 18 - 45 years at enrollment
- Female participants, born female
- Willing and able to
- communicate in English
- complete all required study procedures
- Subjects willing to abstain from vaginal intercourse and use of vaginal products for the first week of the study and until cleared by the study physician.
Who cannot join
- Participant reports any of the following:
- Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) within 21 days prior to Enrollment Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap smear as well as IUD removal are not exclusionary
- Current use of an IVR (e.g., Nuvaring)
- Prior hysterectomy
- Females who are pregnant based on positive pregnancy test by urine HCG
- Cervicovaginal inflammation or epithelial disruption on colposcopy at the screening examination.
Show all 9Show fewer
- Current active gynecological abnormalities or sexually transmitted infection and/or vaginal pathogens (e.g. gonorrhea, chlamydia, mycoplasma genitalium, trichomonas, candida species, bacterial vaginosis) at the screening examination.
- Note: Subjects may be treated and re-screened for participation.
- Has any other condition or is participating in another research study that, in the opinion of the Principal Investigator or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Safety and Acceptability Study of MM008-IVR, an Antibody-Based Nonhormonal Contraceptive Intravaginal Ring
In order to deliver nonhormonal vaginal contraceptive using anti-sperm antibodies, a new vaginal ring design using a capsule-IVR will be utilized. Evaluating the safety and acceptability of this device early in the product development cycle is important, not only because device/formulation characteristics become increasingly difficult to alter as product is advanced into clinical trials, but also because user adherence can directly impact clinical trial outcomes.
Read the detailed description
There is a gap in commercially available reliable, effective contraception methods that do not contain hormones. Mucommune is developing a novel non-hormonal contraceptive in the form of a capsule-intravaginal ring (IVR) that releases highly potent contraceptive antibodies (MM008) that rapidly bind and trap sperm. These antibodies have been developed over the past 5 years and the target on sperm cells was initially obtained from a patient with infertility due to anti-sperm antibodies.
- Conditions
- Healthy Female Subjects
- Being tested
- Placebo intravaginal ring (IVR)
- Keywords
- Non-hormonal intravaginal ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo intravaginal ring (IVR)Device
Antibody-Based Nonhormonal Placebo Contraceptive Intravaginal Ring
| Study group | Role | What they receive |
|---|---|---|
| Placebo IVR | Experimental | Participants will use a placebo IVR for 14 days. Receives: Device: Placebo intravaginal ring (IVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Product-Related Adverse Events During Placebo IVR Use
Determined by AE's, including colposcopy findings, that are deemed to be product related during placebo IVR use.
Measured: 14 days
Secondary outcomes (1)
Device-only Tolerability and Acceptability
Device tolerability and acceptability as judged by scores on the questionnaires related to placebo IVR use. The scale that is used is a 5 point likert scale that assesses the degree to which the participant agrees or disagrees with a statement regarding the use of the intravaginal ring. Items will be factor analyzed and items will be summed by subscale with a higher score indicating greater agreement or a lower score indicating less agreement with a variety of statements about the ring and their experience of using the ring.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start11 Feb 2025
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Female SubjectsStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study participants will be asked to use a placebo IVR to determine safety and acceptability for 14 days.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Mucommune, LLC., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740253
- Sponsor's protocol ID
- 24-0194
- Other IDs
- 1R43HD108823-01
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2024
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Acceptability Study of MM008-IVR, an Antibody-Based Nonhormonal Contraceptive Intravaginal Ring
- ClinicalTrials.gov ID
- NCT06740253
- Acronym / sponsor ID
- 24-0194
- Conditions
- Healthy Female Subjects
- Keywords
- Non-hormonal intravaginal ring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Mucommune, LLC., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Posted 21 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to deliver nonhormonal vaginal contraceptive using anti-sperm antibodies, a new vaginal ring design using a capsule-IVR will be utilized. Evaluating the safety and acceptability of this device early in the product development cycle is important, not only because device/formulation characteristics become increasingly difficult to alter as product is advanced into clinical trials, but also because user adherence can directly impact clinical trial outcomes.
Detailed description
There is a gap in commercially available reliable, effective contraception methods that do not contain hormones. Mucommune is developing a novel non-hormonal contraceptive in the form of a capsule-intravaginal ring (IVR) that releases highly potent contraceptive antibodies (MM008) that rapidly bind and trap sperm. These antibodies have been developed over the past 5 years and the target on sperm cells was initially obtained from a patient with infertility due to anti-sperm antibodies.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study participants will be asked to use a placebo IVR to determine safety and acceptability for 14 days.
| Arm | Type | Receives |
|---|---|---|
| Placebo IVR | Experimental | Device: Placebo intravaginal ring (IVR)Participants will use a placebo IVR for 14 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provide written informed consent
- Age of 18 - 45 years at enrollment
- Female participants, born female
- Willing and able to
- Subjects willing to abstain from vaginal intercourse and use of vaginal products for the first week of the study and until cleared by the study physician.
Key exclusion criteria (9 listed)
- Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) within 21 days prior to Enrollment Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap smear as well as IUD removal are not exclusionary
- Current use of an IVR (e.g., Nuvaring)
- Prior hysterectomy
- Females who are pregnant based on positive pregnancy test by urine HCG
- Cervicovaginal inflammation or epithelial disruption on colposcopy at the screening examination.
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 (IVR)Antibody-Based Nonhormonal Placebo Contraceptive Intravaginal Ring | Device | Placebo IVR |
Primary outcome
Number of Participants With Product-Related Adverse Events During Placebo IVR Use
Time frame: 14 days
Determined by AE's, including colposcopy findings, that are deemed to be product related during placebo IVR use.
1 secondary outcome
Device-only Tolerability and Acceptability
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 study of Healthy Female Subjects, run by The University of Texas Medical Branch, Galveston 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 7 inclusion and 9 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 22 Oct 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With Product-Related Adverse Events During Placebo IVR Use (time frame: 14 days). 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 22 Oct 2026.