An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis

Summary

1. Rationale Bacterial vaginosis (BV) is caused by an overgrowth of bacteria and affects most women at some point. The infections can cause foul-smelling discharge and sometimes itching and burning. There are already some approved medications for the treatment of BV. They are not always effective, which means that the infection often returns. Many of these treatments contain antibiotics. In this study, a medical device will be evaluated, a vaginal tablet called pHyph.

pHyph contains a substance that occurs naturally in the body, Glucono-delta-lactone, which is part of the process when the body handles sugar. It is also an approved food additive. In pHyph, Glucono-delta-lactone restores the acidity of the vagina to normal. In a slightly acidic environment, the bacteria that cause bacterial vaginosis do not thrive, but instead the lactobacilli that are found in a normal vaginal bacterial flora are favored.
2. Aim

Primary aim:

To evaluate the safety after 12 days of treatment with pHyph in patients with BV

Secondary aims:

1. To investigate the difference in the frequency of vaginal dysbiosis after daily treatment for 6 days with pHyph compared to longer daily treatment.
2. To investigate changes in different Lactobacillus species after daily treatment for 6 days with pHyph compared to longer daily treatment.
3. To investigate the difference in clinical efficacy after daily treatment for 6 days with pHyph compared to longer daily treatment.
4. To investigate the relief of the symptom of "fishy odor" after daily treatment for 6 days with pHyph compared to longer daily treatment

Exploratory aims:

To evaluate vaginal microbiome data after different treatment durations in patients with BV 4. Primary outcome measure

To assess the safety and well-tolerated nature of the treatment for patients receiving treatment for a total of 12 days:

1. By monitoring and recording any adverse events that occur during the treatment period, from the first visit to the fourth visit.
2. By assessing for signs of redness, swelling or irritation of the vaginal mucosa using a rating scale from 0 to 3, at days 0, 7, 14 and 25.

5\. Secondary outcome measure

The study will compare changes during and after treatment at different time points (days 0, 7, 10, 14 and 25). Among other things, the following are being looked at:

* Presence of bacterial imbalance in the vagina
* Amount of different beneficial Lactobacillus bacteria
* Proportion of patients who recover from symptoms such as foul-smelling or abnormal discharge
* Change in vaginal pH and possible presence of vaginal yeast
* How easy and user-friendly the treatment is perceived according to patients' responses in an app Exploratory outcome measure To further evaluate vaginal microbiome data after different treatment lengths in patients with bacterial vaginosis (BV).

6\. Study design 32 women with BV are planning to be included in the study. The aim is to evaluate the safety after 12 days of treatment (days 0-5 and days 7-12) with pHyph in patients with BV.

7\. Study population The study will include women who have had their period but have not yet reached menopause, are 18 years of age or older and are seeking treatment, directly at a clinic or via advertising, for symptoms of BV, such as foul-smelling or abnormal discharge. The diagnosis of BV is made according to the Amsel criteria, defined as having at least three of the following criteria: thin whitish-yellow discharge, special cells visible under a microscope, a vaginal pH value higher than 4.5, and a distinct fishy odor when a basic substance is added (this symptom must be present). Women with signs of other vaginal infections will not be able to participate in the study.

8\. Interventions The study includes four clinic visits over a period of approximately 25 days. All participants receive active treatment with pHyph vaginal tablets, which are inserted vaginally at home in the evening with a CE marked applicator. Exact instructions are given at the first visit. At the four clinic visits, which are made on days 0, 7, 14 and 25, a gynecological examination is performed and samples are taken. Between visits, participants answer questions about BV symptoms and treatment via a mobile app.
* Visit 1 (Inclusion visit): with information, consent and pregnancy test. A gynecological examination and a sample for BV control are performed. The participant is given an applicator and tablets for 6 days of treatment to use at home every evening.
* Visit 2 (Day 7): A new gynecological examination and a sample for BV control. The participant is given an additional 6 days of tablets. A sample for BV control is taken at home on Day 10.
* Visit 3 (Day 14): A new gynecological examination and a sample for BV control and questions about the ease of use of the product.
* Visit 4 (Day 25): Follow-up visit with a new gynecological examination, sample for BV control, pregnancy test and questions about health and menstruation.

Conditions

• Bacterial Vaginosis (BV)

Interventions

DEVICE

pHyph

pHyph is a vaginal tablet

Sponsors & Collaborators

• Gedea Biotech AB

  lead INDUSTRY

• CTC Clinical Trial Consultants AB

  collaborator INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-15

Primary Completion

2026-04-01

Completion

2026-04-01

Countries

• Sweden

Study Locations