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Colposeptine for the Treatment of Bacterial Vaginosis

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ClinicalTrials.gov Identifier: NCT01153958
Recruitment Status : Terminated
First Posted : June 30, 2010
Results First Posted : August 21, 2012
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Merck Serono Co., Ltd., China
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Vaginosis, Bacterial
Interventions Drug: Colposeptine
Drug: Metronidazole
Enrollment 133
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Colposeptine Metronidazole
Hide Arm/Group Description Colposeptine 1 capsule transvaginally daily for 12 consecutive days. Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Period Title: Overall Study
Started 66 67
Completed 30 35
Not Completed 36 32
Reason Not Completed
Study Terminated             36             32
Arm/Group Title Colposeptine Metronidazole Total
Hide Arm/Group Description Colposeptine 1 capsule transvaginally daily for 12 consecutive days. Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days Total of all reporting groups
Overall Number of Baseline Participants 66 67 133
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 67 participants 133 participants
32.11  (8.78) 30.72  (7.06) 31.41  (7.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 67 participants 133 participants
Female
66
 100.0%
67
 100.0%
133
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Relapse 2 Months Post-treatment
Hide Description 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.
Time Frame 2 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.
Arm/Group Title Colposeptine Metronidazole
Hide Arm/Group Description:
Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Overall Number of Participants Analyzed 30 35
Measure Type: Number
Unit of Measure: percentage of participants
23.3 17.2
2.Secondary Outcome
Title Percentage of Participants With Relapse 1 Month Post-treatment
Hide Description 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.
Time Frame 1 month post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.
Arm/Group Title Colposeptine Metronidazole
Hide Arm/Group Description:
Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Overall Number of Participants Analyzed 25 28
Measure Type: Number
Unit of Measure: percentage of participants
16.0 10.7
3.Secondary Outcome
Title Change From Baseline in Nugent Score at 2 Months Post-treatment
Hide Description 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.
Time Frame Baseline and Month 2 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who used investigational product. 'n' signifies those participants who were evaluated for this measure at the time point.
Arm/Group Title Colposeptine Metronidazole
Hide Arm/Group Description:
Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Overall Number of Participants Analyzed 66 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n= 66, 67) 7.86  (0.58) 8.01  (0.59)
Change at Month 2 (n= 25, 29) 3.20  (2.12) 4.03  (2.71)
4.Secondary Outcome
Title Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment
Hide Description 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.
Time Frame Baseline and Month 2 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at the time point.
Arm/Group Title Colposeptine Metronidazole
Hide Arm/Group Description:
Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Overall Number of Participants Analyzed 66 66
Measure Type: Number
Unit of Measure: participants
Baseline, Grade 1 (n= 66, 66) 0 0
Baseline, Grade 2 (n= 66, 66) 3 1
Baseline, Grade 3 (n= 66, 66) 63 65
Month 2, Grade 1 (n= 25, 29) 11 9
Month 2, Grade 2 (n= 25, 29) 7 14
Month 2, Grade 3 (n= 25, 29) 7 6
5.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description 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.
Time Frame Up to 2 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who used the investigational product at least once.
Arm/Group Title Colposeptine Metronidazole
Hide Arm/Group Description:
Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Overall Number of Participants Analyzed 66 67
Measure Type: Number
Unit of Measure: participants
8 8
6.Secondary Outcome
Title Percentage of Participants Cured
Hide Description 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.
Time Frame 1 week post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.
Arm/Group Title Colposeptine Metronidazole
Hide Arm/Group Description:
Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Overall Number of Participants Analyzed 48 45
Measure Type: Number
Unit of Measure: percentage of participants
22.9 17.8
Time Frame Baseline up to 2 months post-treatment
Adverse Event Reporting Description 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 IMP, regardless of causal relationship and even if no IMP has been administered.
 
Arm/Group Title Colposeptine Metronidazole
Hide Arm/Group Description Colposeptine 1 capsule transvaginally daily for 12 consecutive days. Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
All-Cause Mortality
Colposeptine Metronidazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Colposeptine Metronidazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/66 (0.00%)      0/67 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Colposeptine Metronidazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/66 (12.12%)      10/67 (14.93%)    
Gastrointestinal disorders     
Abdominal Pain * 1  1/66 (1.52%)  1 0/67 (0.00%)  0
Abdominal Pain Upper * 1  0/66 (0.00%)  0 2/67 (2.99%)  2
Nausea * 1  0/66 (0.00%)  0 3/67 (4.48%)  3
General disorders     
Pyrexia * 1  1/66 (1.52%)  2 0/67 (0.00%)  0
Infections and infestations     
Vulvovaginal Candidiasis * 1  2/66 (3.03%)  2 0/67 (0.00%)  0
Vulvovaginitis Trichomonal * 1  1/66 (1.52%)  1 0/67 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bone Pain * 1  0/66 (0.00%)  0 1/67 (1.49%)  1
Nervous system disorders     
Dizziness * 1  0/66 (0.00%)  0 1/67 (1.49%)  1
Reproductive system and breast disorders     
Vulvovaginal Pruritus * 1  1/66 (1.52%)  1 0/67 (0.00%)  0
Pelvic Pain * 1  1/66 (1.52%)  1 0/67 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  0/66 (0.00%)  0 1/67 (1.49%)  1
Skin and subcutaneous tissue disorders     
Rash * 1  1/66 (1.52%)  1 2/67 (2.99%)  2
Surgical and medical procedures     
Endodontic Procedure * 1  1/66 (1.52%)  1 0/67 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01153958     History of Changes
Other Study ID Numbers: EMR200059-504
First Submitted: June 28, 2010
First Posted: June 30, 2010
Results First Submitted: July 18, 2012
Results First Posted: August 21, 2012
Last Update Posted: February 13, 2014