A Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health

NCT07435350 | Active Not Recruiting

• 1 other identifier: RADX_C026_DSH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health.

Conditions

Vaginal Health

Outcome Measures

Primary Outcomes (1)

• Colonization of VV-01 probiotic strains in the vagina

  Colonization of VV-01 probiotic strains in the vagina assessed using strain-specific qPCR from vaginal swabs

  Baseline to Day 14

Secondary Outcomes (3)

• Vaginal microbial ecosystem structure

  Baseline to Day 14

• Biogenic amines production capability in the vaginal microbiome

  Baseline to Day 14

• Safety and tolerability

  Baseline to Day 14

Other Outcomes (1)

• Vaginal pH

  Baseline to Day 14

Study Arms (2)

Active VV-01

ACTIVE COMPARATOR

Vaginal Health Active VV-01

Dietary Supplement: Vaginal Health Active VV-01

Placebo Control

PLACEBO COMPARATOR

Vaginal Health Placebo Control

Dietary Supplement: Vaginal Health Placebo Control

Interventions

Vaginal Health Placebo Control DIETARY_SUPPLEMENT

Vaginal Health Placebo Control Participants will orally ingest Vaginal Health Placebo Control once daily as directed for a period of 2 weeks

Placebo Control

Vaginal Health Active VV-01 DIETARY_SUPPLEMENT

Product 1 Participants will orally ingest Vaginal Health Active Product 1 once daily as directed for a period of 2 weeks.

Active VV-01

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all the following criteria:
• Healthy women with a vagina 21 - 60 years old at the time of electronic consent
• Sex assigned female at birth
• Eligible menstrual status:
• Pre-menopausal is defined as women in their childbearing years who must have a regular menstrual cycle (consistently average cycle length of 21 to 35 days) Note: Women in their childbearing years who do not have a regular menstrual cycle due to a hormone-based intrauterine device are eligible
• Peri-menopausal is defined as women who report irregular periods (differences in menstruation compared with their typical cycle in their 20s), with at least 1 period in the last 12 months AND report mild menopausal symptoms (e.g., vasomotor symptoms such as hot flashes, night sweats)
• Post-menopausal is defined as women with an absence of menstrual cycle for the last 12 consecutive months or longer
• Willing to ingest an oral capsule during the study and be blinded to product identity (active or placebo)
• Willing to self-collect vaginal swabs and pH samples
• Willing to abstain from the use of intravaginal products during the study period (e.g., vaginal suppositories, vaginal moisturizers including hyaluronic acid, boric acid suppositories, pH balancing wipes, douching, vaginal creams/gels), as well as lubrication and spermicides
• Able to read and comprehend English and provide electronic informed consent
• Resides in the United States

You may not qualify if:

• Active vaginal, pelvic, or urogenital infection (e.g., UTI, BV, yeast infection)
• Chronic vulvar and vaginal conditions (e.g., vulvodynia, lichen sclerosis and lichen planus, desquamative inflammatory vaginitis)
• Unexplained vaginal bleeding
• Use of copper-based intrauterine devices
• Note: Hormone-based intrauterine devices are permitted (e.g., Mirena®)
• For peri-menopausal and post-menopausal individuals, use of estrogen-based vaginal cream/gel or suppositories
• Women who have undergone surgical menopause (e.g., bilateral oophorectomy with or without hysterectomy)
• Current or recent use (\< 3 months prior to enrollment) of antibiotics or antifungals, or anticipated use during study period (e.g., perioperative antibiotics for upcoming elective procedures)
• Current or recent use (\<4 weeks prior to enrollment) of any other probiotic, prebiotic or synbiotic-containing products
• Note: Individuals who undergo a washout of 4-weeks prior to enrollment and are willing to abstain from consuming such products during the study are permitted. Food-based probiotics, prebiotics, and synbiotics are permitted (e.g., kimchi, yoghurt, kefir, kombucha)
• Pregnant, breastfeeding, or actively trying to conceive during the study period.
• Allergy to any ingredients in the investigational or placebo product.
• Receiving chronic oral steroid therapy (excluding those for skin, eyes, nose, or inhaled) or have received such treatment within 4 weeks of enrollment
• Surgery, immunotherapy, chemotherapy, radiation, or biological cancer therapy within 4 weeks of enrollment and/or planned during the next 2 weeks
• Diagnosed and active serious medical condition requiring current treatment (e.g., cancer; autoimmune diseases \[lupus, rheumatoid arthritis, Crohn's disease\]; serious cardiac, liver, endocrine (insulin-dependent diabetes and/or on SGLT2 inhibitors such as Jardiance®/Empagliflozin, Farxiga®/Dapagliflozin) or kidney disease; psychiatric conditions / substance use disorders; chronic infections \[HIV, Hepatitis B/C\], any condition which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014-2605, United States

Location

Related Links

• Related Info

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator): The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment. Participants will be sequentially randomized to one of two study groups, with an equal (1:1) chance of receiving the study product or placebo

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): February 26, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)