Trial Outcomes & Findings for Colposeptine for the Treatment of Bacterial Vaginosis (NCT NCT01153958)

Last Updated: 2014-02-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

133 participants

Primary outcome timeframe

2 months post-treatment

Results posted on

2014-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Colposeptine Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Overall Study STARTED	66	67
Overall Study COMPLETED	30	35
Overall Study NOT COMPLETED	36	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Colposeptine Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Overall Study Study Terminated	36	32

Baseline Characteristics

Colposeptine for the Treatment of Bacterial Vaginosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colposeptine n=66 Participants Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole n=67 Participants Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days	Total n=133 Participants Total of all reporting groups
Age, Continuous	32.11 years STANDARD_DEVIATION 8.78 • n=5 Participants	30.72 years STANDARD_DEVIATION 7.06 • n=7 Participants	31.41 years STANDARD_DEVIATION 7.95 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months post-treatment

Population: 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.

Outcome measures

Outcome measures
Measure	Colposeptine n=30 Participants Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole n=35 Participants Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Percentage of Participants With Relapse 2 Months Post-treatment	23.3 percentage of participants	17.2 percentage of participants

SECONDARY outcome

Timeframe: 1 month post-treatment

Population: FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.

Outcome measures

Outcome measures
Measure	Colposeptine n=25 Participants Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole n=28 Participants Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Percentage of Participants With Relapse 1 Month Post-treatment	16.0 percentage of participants	10.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Month 2 post-treatment

Population: FAS population included all enrolled participants who used investigational product. 'n' signifies those participants who were evaluated for this measure at the time point.

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.

Outcome measures

Outcome measures
Measure	Colposeptine n=66 Participants Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole n=67 Participants Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Change From Baseline in Nugent Score at 2 Months Post-treatment Baseline (n= 66, 67)	7.86 units on a scale Standard Deviation 0.58	8.01 units on a scale Standard Deviation 0.59
Change From Baseline in Nugent Score at 2 Months Post-treatment Change at Month 2 (n= 25, 29)	3.20 units on a scale Standard Deviation 2.12	4.03 units on a scale Standard Deviation 2.71

SECONDARY outcome

Timeframe: Baseline and Month 2 post-treatment

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Colposeptine n=66 Participants Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole n=66 Participants Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment Baseline, Grade 1 (n= 66, 66)	0 participants	0 participants
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment Baseline, Grade 2 (n= 66, 66)	3 participants	1 participants
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment Baseline, Grade 3 (n= 66, 66)	63 participants	65 participants
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment Month 2, Grade 1 (n= 25, 29)	11 participants	9 participants
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment Month 2, Grade 2 (n= 25, 29)	7 participants	14 participants
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment Month 2, Grade 3 (n= 25, 29)	7 participants	6 participants

SECONDARY outcome

Timeframe: Up to 2 months post-treatment

Population: Safety population included all randomized participants who used the investigational product at least once.

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.

Outcome measures

Outcome measures
Measure	Colposeptine n=66 Participants Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole n=67 Participants Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Number of Participants With Adverse Events (AEs)	8 participants	8 participants

SECONDARY outcome

Timeframe: 1 week post-treatment

Population: FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.

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.

Outcome measures

Outcome measures
Measure	Colposeptine n=48 Participants Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole n=45 Participants Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Percentage of Participants Cured	22.9 percentage of participants	17.8 percentage of participants

Adverse Events

Colposeptine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Metronidazole

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Colposeptine n=66 participants at risk Colposeptine 1 capsule transvaginally daily for 12 consecutive days.	Metronidazole n=67 participants at risk Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/66 • Baseline up to 2 months post-treatment 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.	1.5% 1/67 • Number of events 1 • Baseline up to 2 months post-treatment 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.
Gastrointestinal disorders Abdominal Pain	1.5% 1/66 • Number of events 1 • Baseline up to 2 months post-treatment 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.	0.00% 0/67 • Baseline up to 2 months post-treatment 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.
Reproductive system and breast disorders Vulvovaginal Pruritus	1.5% 1/66 • Number of events 1 • Baseline up to 2 months post-treatment 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.	0.00% 0/67 • Baseline up to 2 months post-treatment 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.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/66 • Baseline up to 2 months post-treatment 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.	3.0% 2/67 • Number of events 2 • Baseline up to 2 months post-treatment 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.
Nervous system disorders Dizziness	0.00% 0/66 • Baseline up to 2 months post-treatment 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.	1.5% 1/67 • Number of events 1 • Baseline up to 2 months post-treatment 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.
Infections and infestations Vulvovaginal Candidiasis	3.0% 2/66 • Number of events 2 • Baseline up to 2 months post-treatment 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.	0.00% 0/67 • Baseline up to 2 months post-treatment 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.
Gastrointestinal disorders Nausea	0.00% 0/66 • Baseline up to 2 months post-treatment 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.	4.5% 3/67 • Number of events 3 • Baseline up to 2 months post-treatment 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.
Surgical and medical procedures Endodontic Procedure	1.5% 1/66 • Number of events 1 • Baseline up to 2 months post-treatment 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.	0.00% 0/67 • Baseline up to 2 months post-treatment 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.
Infections and infestations Vulvovaginitis Trichomonal	1.5% 1/66 • Number of events 1 • Baseline up to 2 months post-treatment 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.	0.00% 0/67 • Baseline up to 2 months post-treatment 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.
Skin and subcutaneous tissue disorders Rash	1.5% 1/66 • Number of events 1 • Baseline up to 2 months post-treatment 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.	3.0% 2/67 • Number of events 2 • Baseline up to 2 months post-treatment 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.
General disorders Pyrexia	1.5% 1/66 • Number of events 2 • Baseline up to 2 months post-treatment 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.	0.00% 0/67 • Baseline up to 2 months post-treatment 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.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/66 • Baseline up to 2 months post-treatment 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.	1.5% 1/67 • Number of events 1 • Baseline up to 2 months post-treatment 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.
Reproductive system and breast disorders Pelvic Pain	1.5% 1/66 • Number of events 1 • Baseline up to 2 months post-treatment 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.	0.00% 0/67 • Baseline up to 2 months post-treatment 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.

Additional Information

Merck KGaA Communication Center

Merck Serono, a division of Merck KGaA

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER