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Trial record 35 of 415 for:    Vaginal Diseases: Clinical Trials

Colposeptine for the Treatment of Bacterial Vaginosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Colposeptine Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
Metronidazole Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days

Participant Flow:   Overall Study
    Colposeptine   Metronidazole
STARTED   66   67 
COMPLETED   30   35 
NOT COMPLETED   36   32 
Study Terminated                36                32 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Colposeptine Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
Metronidazole Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Total Total of all reporting groups

Baseline Measures
   Colposeptine   Metronidazole   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   67   133 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.11  (8.78)   30.72  (7.06)   31.41  (7.95) 
Gender 
[Units: Participants]
     
Female   66   67   133 
Male   0   0   0 


  Outcome Measures

1.  Primary:   Percentage of Participants With Relapse 2 Months Post-treatment   [ Time Frame: 2 months post-treatment ]

2.  Secondary:   Percentage of Participants With Relapse 1 Month Post-treatment   [ Time Frame: 1 month post-treatment ]

3.  Secondary:   Change From Baseline in Nugent Score at 2 Months Post-treatment   [ Time Frame: Baseline and Month 2 post-treatment ]

4.  Secondary:   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 ]

5.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Up to 2 months post-treatment ]

6.  Secondary:   Percentage of Participants Cured   [ Time Frame: 1 week post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com



Responsible Party: Merck KGaA
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