Trial · NCT01230814
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
NCT01230814, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2014-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women. Trials, record NCT01230814. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01230814
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
- NCT number
- NCT01230814
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 234 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Bacterial Vaginosis, Candidiasis, Trichomoniasis
- Interventions
- Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate), Placebo
- First posted
- 2010-10-29
- Last updated
- 2014-10-06
- Results first posted
- 2014-09-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC). | Months 2, 4, 6, 8, 10, and 12. | Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for VVC based on the presence of fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud's agar. |
| Primary | Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV). | Months 2, 4, 6, 8, 10, and 12. | Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV as determined by applying standard microscopic scoring criteria (Nugent's criteria) to vaginal Gram stained slides. BV is diagnosed when the score is greater than or equal to 7. |
| Secondary | Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection). | Months 2, 4, 6, 8, 10, and 12. | Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for any of three vaginal infections (BV, VVC, Trichomonas vaginalis infection). |
| Secondary | Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel's Criteria). | Months 2, 4, 6, 8, 10, and 12. | Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV by clinical criteria (Amsel's criteria). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC). | Months 2, 4, 6, 8, 10, and 12. | Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment. | percentage of follow-up visits | NUMBER |
| PRIMARY | Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV). | Months 2, 4, 6, 8, 10, and 12. | Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment. | percentage of follow-up visits | NUMBER |
| SECONDARY | Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection). | Months 2, 4, 6, 8, 10, and 12. | Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment. | percentage of follow-up visits | NUMBER |
| SECONDARY | Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel's Criteria). | Months 2, 4, 6, 8, 10, and 12. | Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment. | percentage of follow-up visits | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC). | Arm 1: Metronidazole Plus Miconazole | 10.4 | 95% Confidence Interval 8.2 to 13.2 | percentage of follow-up visits | |
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC). | Arm 2: Placebo | 11.3 | 95% Confidence Interval 9.0 to 14.1 | percentage of follow-up visits | |
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV). | Arm 1: Metronidazole Plus Miconazole | 21.2 | 95% Confidence Interval 18.0 to 25.1 | percentage of follow-up visits | |
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV). | Arm 2: Placebo | 32.5 | 95% Confidence Interval 28.4 to 37.1 | percentage of follow-up visits | |
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection). | Arm 1: Metronidazole Plus Miconazole | 32.6 | 95% Confidence Interval 28.4 to 37.3 | percentage of follow-up visits | |
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection). | Arm 2: Placebo | 46.5 | 95% Confidence Interval 41.6 to 51.9 | percentage of follow-up visits | |
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel's Criteria). | Arm 1: Metronidazole Plus Miconazole | 14.4 | 95% Confidence Interval 11.8 to 17.7 | percentage of follow-up visits | |
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel's Criteria). | Arm 2: Placebo | 18.2 | 95% Confidence Interval 15.2 to 21.7 | percentage of follow-up visits |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Metronidazole Plus Miconazole | 118 | |
| Overall Study | STARTED | Arm 2: Placebo | 116 | |
| Overall Study | COMPLETED | Arm 1: Metronidazole Plus Miconazole | 105 | |
| Overall Study | COMPLETED | Arm 2: Placebo | 112 | |
| Overall Study | NOT COMPLETED | Arm 1: Metronidazole Plus Miconazole | 13 | |
| Overall Study | NOT COMPLETED | Arm 2: Placebo | 4 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Arm 1: Metronidazole Plus Miconazole | 8 | 116 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | Arm 2: Placebo | 17 | 116 | 21 |
| other | Abdominal pain lower | Gastrointestinal disorders | Arm 1: Metronidazole Plus Miconazole | 14 | 116 | 17 |
| other | Abdominal pain lower | Gastrointestinal disorders | Arm 2: Placebo | 9 | 116 | 12 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Arm 1: Metronidazole Plus Miconazole | 10 | 116 | 11 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Arm 2: Placebo | 9 | 116 | 12 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Arm 1: Metronidazole Plus Miconazole | 21 | 116 | 25 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Arm 2: Placebo | 11 | 116 | 13 |
| other | Body tinea | Infections and infestations | Arm 1: Metronidazole Plus Miconazole | 8 | 116 | 8 |
| other | Body tinea | Infections and infestations | Arm 2: Placebo | 8 | 116 | 10 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Metronidazole Plus Miconazole | ||
| Total, all-cause mortality | Arm 2: Placebo | ||
| Total, other adverse events | Arm 1: Metronidazole Plus Miconazole | 109 | 116 |
| Total, other adverse events | Arm 2: Placebo | 111 | 116 |
| Total, serious adverse events | Arm 1: Metronidazole Plus Miconazole | 3 | 116 |
| Total, serious adverse events | Arm 2: Placebo | 1 | 116 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1: Metronidazole Plus Miconazole vs Arm 2: Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01230814
GET https://conductscience.org/api/trials/v1/NCT01230814/events?page=2