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RecruitingNCT05963711Updated Sep 23, 2026

The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation

An interventional study of chlorhexidine gluconate 4% in Bacterial Vaginosis and Microbial Colonization, sponsored by Hadassah Medical Organization. Recruiting at 1 site in Israel. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Oct 2022, registered Jul 2023).
  • Started Oct 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

There is strong observational evidence that sexual activity plays a key role in Bacterial Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria (BVAB) between sexual partners.

Although BV epidemiology strongly suggests sexual transmission, treatment of sexual partners is not recommended, based on prior treatment studies of male partners of women with recurrent BV, which showed no benefit with male treatment. Nevertheless, male condom use is highly protective against recurrent BV.

This study aims to evaluate the male-partner's genital microbiome as a potential source of BV-recurrence in women undergoing vaginal microbiota transplantation (NCT04517487), and whether disinfection can eliminate BV-associated penile microbiome.

02

Conditions studied

  • Bacterial Vaginosis
  • Microbial Colonization

Keywords

  • Penile microbiome
  • Vaginal microbiome transplant
  • Male partners
  • Bacterial vaginosis
03

In context

Vaginosis, Bacterial

240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 675 studies on the registry; 54 are open to participants now.

Browse Hadassah Medical Organization studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The subject has s female partner who participates in VMT study ( NCT04517487).
  • The subject is defined by the woman as her male regular partner.
  • Willing to use a condom as instructed by the protocol.
  • Willing to comply with decolonization protocol.

Exclusion criteria

Exclusion Criteria:

  • A known skin disease involving the penile skin.
  • A known sensitivity to chlorhexidine gluconate
  • Any of the partners (female/male) has more than one sexual partner.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Interventions

  • Otherchlorhexidine gluconate 4%

    In case BV associated bacteria will be identified (using molecular sequencing) in male samples, decolonization attempt will be conducted, using a daily wash for 5 days with chlorhexidine gluconate 4%. Following decolonization attempt, male participants will undergo re- sampling, to assess for microbiome changes. In case there is no change in microbial composition, partners will be instructed to repeat decolonization protocol, and apply a 2 cm diameter volume of 2% clindamycin cream topically to the head of the penis and upper shaft (under the foreskin if uncircumcised) twice daily for seven days following repeated decolonization. Re-sampling will follow.

    Also known as: 2% clindamycin cream

06

What researchers measure

Primary outcomes

  1. Penile microbiome composition

    Characterization of the penile microbial communities using shotgun analysis, and their similarity to the vaginal microbiota composition of their sexual partner.

    Time frame: 1 year

  2. Penile microbiome composition after disinfection

    Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Dec 2026, 50 months after the start.

Of 52 interventional studies with no phase under Vaginosis, Bacterial, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 56. This study's planned 50 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2023
First posted
Jul 27, 2023
StartActual
Oct 17, 2022
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05963711
Lead sponsor
Hadassah Medical Organization
Responsible party
Ahinoam Lev-Sagie (Professor, Hadassah Medical Organization) — Principal investigator
First posted
Jul 27, 2023
Start date
Oct 17, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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