CLINICAL TRIALS PROFILE FOR METROGEL-VAGINAL

All Clinical Trials for METROGEL-VAGINAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02766023 ↗	LACTIN-V Study for Recurrent Bacterial Vaginosis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2016-06-03	This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that, following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week incidence of BV recurrence when compared to placebo. The primary objectives of this study are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.
NCT02376972 ↗	Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis	Terminated	Parexel	Phase 2	2015-04-01	THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS
NCT02376972 ↗	Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis	Terminated	Alfa Wassermann S.p.A.	Phase 2	2015-04-01	THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS
NCT02376972 ↗	Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis	Terminated	Alfasigma S.p.A.	Phase 2	2015-04-01	THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS
NCT01020396 ↗	Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis	Completed	Teva Pharmaceuticals USA	Phase 1/Phase 2	2002-01-01	The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical equivalence in the treatment of bacterial vaginosis.
NCT01020877 ↗	Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects	Completed	Teva Pharmaceuticals USA	Phase 1	2001-11-01	The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female subjects.

Clinical Trial Conditions for METROGEL-VAGINAL

Condition Name

Condition Name for METROGEL-VAGINAL
Intervention	Trials
Bacterial Vaginosis	3
Healthy	1
Post-Op Infection	1

Condition MeSH

Condition MeSH for METROGEL-VAGINAL
Intervention	Trials
Vaginosis, Bacterial	3
Vaginal Diseases	3

Clinical Trial Locations for METROGEL-VAGINAL

Trials by Country

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Trials by Country for METROGEL-VAGINAL
Location	Trials
United States	23

Trials by US State

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−

Trials by US State for METROGEL-VAGINAL
Location	Trials
Pennsylvania	3
New York	2
Illinois	2
California	2
Missouri	1

Clinical Trial Progress for METROGEL-VAGINAL

Clinical Trial Phase

Clinical Trial Phase for METROGEL-VAGINAL
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for METROGEL-VAGINAL
Clinical Trial Phase	Trials
Completed	3
Recruiting	1
Terminated	1

Clinical Trial Sponsors for METROGEL-VAGINAL

Sponsor Name

Sponsor Name for METROGEL-VAGINAL
Sponsor	Trials
Teva Pharmaceuticals USA	2
Parexel	1
Alfa Wassermann S.p.A.	1

Sponsor Type

Sponsor Type for METROGEL-VAGINAL
Sponsor	Trials
Industry	5
NIH	1
Other	1

MetroGel-Vaginal: Clinical Trials, Market Analysis, and Projections

Introduction to MetroGel-Vaginal

MetroGel-Vaginal, containing metronidazole, is a widely used treatment for bacterial vaginosis (BV), a common vaginal infection affecting women of reproductive age. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Efficacy and Trials

Treatment Outcomes

Clinical trials have consistently shown the efficacy of metronidazole vaginal gel in treating BV. A double-blind, placebo-controlled crossover trial demonstrated that 0.75% metronidazole vaginal gel resulted in a clinical cure in 87% to 91% of women with BV[1].

In another study, the FDA-approved Nuvessa™ (metronidazole vaginal gel 1.3%) showed a cure rate of 37.2% in subjects receiving the gel, compared to 26.6% for those receiving a vehicle gel, with a statistically significant difference[2].

Specific Trials and Findings

• Placebo-Controlled Trials: A study involving 53 women with BV found that 26 out of 30 women (87%) who received metronidazole gel were free of BV 9-21 days after treatment, compared to only 4 out of 23 (17%) who received a placebo[1].
• Crossover Trials: Women who did not respond to the initial treatment were crossed over to metronidazole gel, resulting in a cure rate of 91% at the 2-week follow-up[1].
• Pediatric Population: A study conducted to assess the safety and tolerability of metronidazole vaginal gel 1.3% in adolescent females (ages 12 to <18 years) found the treatment to be safe and tolerable, with efficacy extrapolated from adult studies[2].

Preoperative Use

A randomized controlled trial evaluated the use of vaginal metronidazole for 5 days before hysterectomy to reduce postoperative infections. However, this study found no significant difference in postoperative infections or patient-reported issues between the treatment and control groups[4].

Market Analysis

Market Size and Growth

The global bacterial vaginosis (BV) Rx drug market, which includes MetroGel-Vaginal, is expected to grow significantly. By 2033, the market is projected to be worth around USD 2.5 billion, up from USD 1.1 billion in 2023, with a CAGR of 8.9% during the forecast period[3].

Market Segmentation

• Drug Class: Antibiotics, including metronidazole, account for 42% of the market share in 2023[3].
• Route of Administration: Oral administration dominates the market with 59% of the share, but vaginal administration, such as MetroGel-Vaginal, remains a significant segment[3].
• Distribution Channel: Retail pharmacies are the primary distribution channel, accounting for 47% of the market share[3].

Regional Analysis

North America holds a substantial market share of 40.5% in the BV Rx drug market, indicating a strong presence of MetroGel-Vaginal in this region[3].

Trends and Opportunities

Personalized Medicine

There is a growing emphasis on personalized medicine, tailoring treatment plans based on individual patient profiles, including genetic, environmental, and lifestyle factors. This trend could influence the future development and prescription of MetroGel-Vaginal[3].

Non-Antibiotic Treatments

Due to concerns over antibiotic resistance, there is a shift towards the development of non-antibiotic treatments. Probiotics and other alternative therapies are being researched as more sustainable and long-term solutions for BV treatment[3].

Innovative Therapeutic Approaches

The development of novel drug delivery systems, such as topical applications and sustained-release formulations, offers potential for enhanced treatment efficacy and patient adherence. Research into the microbiome’s role in BV and targeted therapies presents a promising avenue for market expansion[3].

Challenges and Restraints

Antibiotic Resistance

Antibiotic resistance remains a significant challenge in the BV Rx drug market. The overuse and misuse of antibiotics have led to the emergence of resistant strains, complicating treatment protocols and necessitating the development of new drugs[3].

Side Effects and Compliance

Long-term antibiotic use can lead to side effects that deter patient compliance. Ensuring patient adherence to treatment regimens, such as the use of MetroGel-Vaginal, is crucial for effective treatment outcomes[2].

Future Projections

Emerging Therapies

The launch of novel developmental candidates, such as Siolta Therapeutics' STMC-105 and Gedea Biotech's pHyph, is expected to transform the BV market landscape. These emerging therapies are poised to offer new standards of care and unlock opportunities for medical innovation and economic growth[5].

Market Dynamics

Advanced scientific technology and sustainability are projected to play major roles in shaping the BV drug market. The integration of new technologies and the focus on sustainable treatments will likely influence the future of MetroGel-Vaginal and other BV treatments[5].

Key Takeaways

• Clinical Efficacy: MetroGel-Vaginal has been shown to be highly effective in treating BV, with cure rates ranging from 87% to 91%.
• Market Growth: The global BV Rx drug market is expected to grow at a CAGR of 8.9% from 2023 to 2033.
• Trends: There is a growing emphasis on personalized medicine and non-antibiotic treatments due to antibiotic resistance concerns.
• Challenges: Antibiotic resistance and patient compliance remain significant challenges.
• Future Projections: Emerging therapies and innovative drug delivery systems are expected to shape the future of BV treatment.

FAQs

Q1: What is the primary indication for MetroGel-Vaginal?

MetroGel-Vaginal is primarily indicated for the treatment of bacterial vaginosis (BV) in non-pregnant women.

Q2: How effective is MetroGel-Vaginal in treating BV?

MetroGel-Vaginal has been shown to result in a clinical cure in 87% to 91% of women with BV in clinical trials.

Q3: What are the common side effects of MetroGel-Vaginal?

Common side effects include vaginal itching, burning, or discharge, though these are generally mild and temporary.

Q4: Can MetroGel-Vaginal be used in pregnant women?

MetroGel-Vaginal is not approved for use in pregnant women. Alternative treatments are recommended for pregnant patients with BV.

Q5: What are the emerging trends in the BV Rx drug market?

Emerging trends include a focus on personalized medicine, the development of non-antibiotic treatments, and innovative drug delivery systems.

Sources

1. PubMed: Efficacy of intravaginal 0.75% metronidazole gel for the treatment of bacterial vaginosis.
2. FDA: CLINICAL REVIEW - Nuvessa™ (metronidazole vaginal gel 1.3%).
3. Market.US: Bacterial Vaginosis Rx Drug Market Size, Share | CAGR of 8.9%.
4. BMJ: A randomized controlled trial of preoperative vaginal metronidazole.
5. GlobeNewswire: Bacterial Vaginosis Market to Register Incremental Growth During the Study Period (2020–2034).