What this trial studies
This study is a double-blind, randomized, controlled trial (RCT) aimed at evaluating the effects of Lactobacillus sp. probiotic administration on the vaginal microbiota changes in postmenopausal women with bacterial vaginosis and how its affect to immunology profile. Postmenopausal women diagnosed with bacterial vaginosis will be recruited as subjects as long as collected period in this study. All patients will receive Metronidazole antibiotic treatment then blind-randomly be divided into two groups: the treatment group, receiving Floragyn® probiotic tablets (Lapi, Indonesia), and the placebo group, receiving Cal 95® (Lapi, Indonesia).
Conditions in scope
- Bacterial Vaginosis (BV)
- Menopause
Interventions
- Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia) (Dietary Supplement) — Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis,…
- Metronidazole + Cal95 (Dietary Supplement) — Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis,…
- Floragyn® probiotic tablets (Lapi, Indonesia) (Dietary Supplement) — Given to the control group to ensure the ability of probiotics to maintain a healthy vaginal ecosystem and not the opposite.
Who can join
Women only · Adults (Child, Adult, Older Adult) · Accepts healthy volunteers.
Inclusion criteria
- Postmenopausal with estradiol levels \< 25 mg/ml
- Diagnosed have bacterial vaginosis by an obstetrician and gynecologist
Exclusion criteria
- Medically unable to perform a pap smear examination
- Experiencing vaginal bleeding of unknown cause
- Diagnosed or suspected of having a malignant disease
- Hypersensitivity to the research treatment to be carried out
- In the last 3 months have received hormone therapy
- Suffering from acute infectious diseases of the genital organs
- Using vaginal therapy in any form
- Suffering from systemic diseases
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Kendari | South East Sulawesi | Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice. | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2024-06-26
- Primary completion: 2024-12-31
- Last update posted: 2024-10-28
- First posted: 2024-10-26
Sponsor & contact
Lead sponsor: Hasanuddin University (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Bacterial Vaginosis Status (At 0, 1, and 7 weeks duration of trial)
A health status of woman reproduction diagnosed by nugent score. Nugent score calculations are carried out by looking at bacterial morphology ie Lactobacillus (parallel - sided, gram positive rods), Mobilincus (curved - Gram negative rods), and Gardnerella / Bacteriodes (tiny, gram-variable cocobacilli and rounded, pleomorphic, gram-negative rods with vacuoles). Score 0-3 is normal flora, score 4-6 is intermediate, score 7-10…
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06659380 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.