Vaginosis, BacterialPhase 4NCT01153958
Colposeptine for the Treatment of Bacterial Vaginosis
A Phase 4 study testing Colposeptine and Metronidazole in people with Vaginosis, Bacterial, run by Merck KGaA, Darmstadt, Germany at 5 sites in China.
Trial summary
This is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were planned to be enrolled in various centers in China. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vaginosis, Bacterial
- What is being tested?
- Colposeptine and Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 5 sitesChina
- Study dates
- Jul 2010to Nov 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects in reproductive age and older than 18 year
- Subjects with normal sexual activity
- Subjects with symptoms such as vulva-vaginal irritation or abnormal vaginal discharge
- Subjects with Nugent Score greater than or equal to 7
- Subjects who are willing to use contraception
- Subjects who are willing to refrain from the use of other vaginal products throughout the study
- Subjects who sign informed consent form and agree to follow-up on time
Who cannot join
- Subjects without sexual activity
- Pregnant or lactating female subjects
- Subjects with a history of recurrent bacterial vaginosis
- Subjects diagnosed with trichomonas vaginitis，vulvovaginal candidiasis，chlamydia or gonococcus infection.
- Subjects who are unwilling to refrain from the ingestion of any alcoholic beverages during the 7 day course of oral metronidazole therapy
- Subjects who are under treatment by lithium, phenobarbitone, coumadine anticoagulant, cyclosporine or disulfiram by the time of inclusion (interactions with other products and metronidazole)
Show all 10Show fewer
- Subjects who are undergoing systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolic agents by the time of inclusion
- Female subjects with a history of peripheral neuropathy
- Female subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days
- Subjects who are unable to give written informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Peking University People's Hospital
Beijing
Second Hospital of West China Medical School, Sichuan University
Chengdu
Obstetrics & Gynaecology Hospital of Fudan University
Shanghai
Peking University Shenzhen Hospital
Shenzhen
Wuhan Union Hospital of China
Wuhan
About this study
Official title: The Use of Colposeptine in Bacterial Vaginosis. A Randomized, Controlled Study
This is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were planned to be enrolled in various centers in China.
- Conditions
- Vaginosis, Bacterial
- Being tested
- Colposeptine, Metronidazole
- Keywords
- Vaginosis, Bacterial, Colposeptine, Metronidazole
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColposeptineDrug
Also called Chlorquinaldol-Promestriene Vaginal Capsules
Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days
MetronidazoleDrug
Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Colposeptine (A) | Experimental | Not described Receives: Drug: Colposeptine |
| Metronidazole (B) | Active comparator | Not described Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Relapse 2 Months Post-treatment
Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.
Measured: 2 months post-treatment
Secondary outcomes (5)
Percentage of Participants With Relapse 1 Month Post-treatment
Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.
Measured: 1 month post-treatment
Change From Baseline in Nugent Score at 2 Months Post-treatment
Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicate bacterial vaginosis.
Measured: Baseline and Month 2 post-treatment
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment
The grades of Lactobacilli in vaginal discharge were Grade 1 (Normal): Lactobacillus morphotypes predominate; Grade 2 (Intermediate): Mixed flora with some Lactobacilli present, but Gardnerella or Mobiluncus morphotypes also present; Grade 3 (Bacterial Vaginosis): Predominantly Gardnerella and/or Mobiluncus morphotypes, few or absent Lactobacilli.
Measured: Baseline and Month 2 post-treatment
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Measured: Up to 2 months post-treatment
Percentage of Participants Cured
Cure was defined as Nugent score less than 7, no symptoms of vaginal irritation (for example, pain, burning, odour or abnormal vaginal discharge). Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated bacterial vaginosis.
Measured: 1 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaginosis, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Co., Ltd., China
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Merck Serono Co., Ltd., China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153958
- Sponsor's protocol ID
- EMR200059-504
- Status last verified
- Jan 2014
- First submitted
- 28 Jun 2010
- Last updated
- 13 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Colposeptine in Bacterial Vaginosis. A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01153958
- Acronym / sponsor ID
- EMR200059-504
- Conditions
- Vaginosis, Bacterial
- Keywords
- Vaginosis, Bacterial, Colposeptine, Metronidazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Co., Ltd., China
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Posted 21 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were planned to be enrolled in various centers in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colposeptine (A) | Experimental | Drug: Colposeptine |
| Metronidazole (B) | Active comparator | Drug: Metronidazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female subjects in reproductive age and older than 18 year
- Subjects with normal sexual activity
- Subjects with symptoms such as vulva-vaginal irritation or abnormal vaginal discharge
- Subjects with Nugent Score greater than or equal to 7
- Subjects who are willing to use contraception
Key exclusion criteria (10 listed)
- Subjects without sexual activity
- Pregnant or lactating female subjects
- Subjects with a history of recurrent bacterial vaginosis
- Subjects diagnosed with trichomonas vaginitis，vulvovaginal candidiasis，chlamydia or gonococcus infection.
- Subjects who are unwilling to refrain from the ingestion of any alcoholic beverages during the 7 day course of oral metronidazole therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColposeptineAlso: Chlorquinaldol-Promestriene Vaginal CapsulesColposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days | Drug | Colposeptine (A) |
| MetronidazoleMetronidazole will be administered orally at a dose of 400 mg twice a day for 7 days | Drug | Metronidazole (B) |
Primary outcome
Percentage of Participants With Relapse 2 Months Post-treatment
Time frame: 2 months post-treatment
Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.
5 secondary outcomes
Percentage of Participants With Relapse 1 Month Post-treatment
Time frame: 1 month post-treatment
Change From Baseline in Nugent Score at 2 Months Post-treatment
Time frame: Baseline and Month 2 post-treatment
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment
Time frame: Baseline and Month 2 post-treatment
Number of Participants With Adverse Events (AEs)
Time frame: Up to 2 months post-treatment
Percentage of Participants Cured
Time frame: 1 week post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Merck Serono Co., Ltd., China
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colposeptine and Metronidazole in people with Vaginosis, Bacterial, run by Merck KGaA, Darmstadt, Germany at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Relapse 2 Months Post-treatment (time frame: 2 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.