An interventional study of pHyph generation I in Bacterial Vaginosis, sponsored by Gedea Biotech AB. Completed at 2 sites in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Gedea Biotech AB · Not applicable, Interventional, and Treatment
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3 of the 4 Amsel criteria. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to 3 Amsel criteria (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability, and adverse events (AEs).
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's enrollment of 24 is below the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Gedea Biotech AB is the lead sponsor of 8 studies on the registry; none are open to participants now.
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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.
Adult, post-menarchal, pre-menopausal women aged 18 years or older
Diagnosis of BV according to Amsel's criteria, defined as having at least 3 of the 4 following criteria:
Exclusion Criteria:
Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.
Device: pHyph generation I
A vaginal tablet for the treatment of BV with administration every 48 hours.
Also known as: Gedea pessary
Clinical Cure Rate
Defined as absence of all of the following 3 Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
Time frame: Day 7
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1
Defined as absence of one of the following Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
Time frame: Day 7 compared to Day 0
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2
Defined as absence of one of the following Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution is added
Time frame: Day 7 compared to Day 0
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3
Defined as absence of one of the following Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odour "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
Time frame: Day 7 compared to Day 0
Usability, Measured by Patient Questionnaire
General assessment of the treatment on a integer scale that ranges from 1 to 10. The lower end of the scale is indicated with the term "Not satisfied" and the higher end with the term "Very satisfied". Question asked: How do you generally regard the treatment?
Time frame: Day 7
Proportion of Patients Having a Recurrence of the BV
Proportion of patients answering Yes to the question "Have the symptoms recurred?"
Time frame: Up to Day 35
| Milestone | pHyph, Gedea Pessary |
|---|---|
| Started | 24 |
| Completed | 21 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Physician decision | 1 |
Defined as absence of all of the following 3 Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
| Participants | pHyph, Gedea Pessary |
|---|---|
| Clinical Cure Rate | 18 |
Defined as absence of one of the following Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
| Participants | pHyph, Gedea Pessary |
|---|---|
| Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1 | 18 |
Defined as absence of one of the following Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution is added
| Participants | pHyph, Gedea Pessary |
|---|---|
| Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2 | 18 |
Defined as absence of one of the following Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odour "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
| Participants | pHyph, Gedea Pessary |
|---|---|
| Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3 | 19 |
General assessment of the treatment on a integer scale that ranges from 1 to 10. The lower end of the scale is indicated with the term "Not satisfied" and the higher end with the term "Very satisfied". Question asked: How do you generally regard the treatment?
| Integer scale (1-10) | pHyph, Gedea Pessary |
|---|---|
| Usability, Measured by Patient Questionnaire | 7.1 ± 2.3 |
Proportion of patients answering Yes to the question "Have the symptoms recurred?"
| Participants | pHyph, Gedea Pessary |
|---|---|
| Day 14 | 1 |
| Day 35 | 0 |
Collected over Up to day 42.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| pHyph, Gedea Pessary | 0/24 (0%) | 0/24 (0%) | 11/24 (45.8%) |
| Event | pHyph, Gedea Pessary |
|---|---|
| HeadacheNervous system disorders | 10/24 |
| DysmenorrhoeaReproductive system and breast disorders | 3/24 |
A total of 24 participants were enrolled, and all 24 participants received study treatment.
| Age, Categorical(Participants) | pHyph, Gedea Pessary |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 24 |
| >=65 years | 0 |
| Age, Continuous(years) | pHyph, Gedea Pessary |
|---|---|
| Mean | 33.1 ± 8.8 |
| Sex: Female, Male(Participants) | pHyph, Gedea Pessary |
|---|---|
| Female | 24 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | pHyph, Gedea Pessary |
|---|
| Region of Enrollment(Participants) | pHyph, Gedea Pessary |
|---|---|
| Sweden | 24 |
| Experience any bacterial vaginosis (BV) infection during the last 12 months(Participants) | pHyph, Gedea Pessary |
|---|---|
| Yes | 16 |
| No | 8 |
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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