BridgeMD
New treatment option for Bacterial Vaginoses
Official title Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
ClinicalTrials.gov ID: NCT04807842
What this study is testing
- What it's testing
- This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (\>20%))
- Women of childbearing potential
- Aged \>18 years
- Signed written informed consent form
- Willing to comply to the follow-up schedule
You likely can't join if
- Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis...
- Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amstel criteria (clue cells detection)
- Current genital malignancies
- Chemotherapy for any reason in last 6 months
- Radiotherapy in the genitourinary system in the last 12 months
- Use of antibiotics for any reason in the last 14 days
See the full eligibility criteria
- Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (\>20%))
- Women of childbearing potential
- Aged \>18 years
- Signed written informed consent form
- Willing to comply to the follow-up schedule
- Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or...
- Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amstel criteria (clue cells detection)
- Current genital malignancies
- Chemotherapy for any reason in last 6 months
- Radiotherapy in the genitourinary system in the last 12 months
- Use of antibiotics for any reason in the last 14 days
- Use of intravaginal devices during the investigation or in the last 14 days
- Pregnancy or currently attempting to conceive
- Lactation
- Use of other treatment for vaginal conditions during the course of the clinical investigation
- Known allergies to ingredients of the product
- Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation
The study team makes the final eligibility decision.
Where it's taking place
- Hamburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamburg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.