Pelvic Inflammatory DiseasePhase 3MAIDENNCT00683865
Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.
A Phase 3 study testing Ofloxacin and Avelox (Moxifloxacin, BAY12-8039) in people with Pelvic Inflammatory Disease, run by Bayer at 77 sites in 13 countries.
Trial summary
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- Ofloxacin and Avelox (Moxifloxacin, BAY12-8039)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 749 participants
- Where
- 77 sitesin 13 countries
- Study dates
- Apr 2003to Oct 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness;
- Adnexal tenderness on bimanual vaginal examination,
- Temperature > 38.0°C; - Elevated C-reactive protein value (CRP);
- Signed PIC/IC
Who cannot join
- Pregnancy
- Abnormal lab values
Trial locations and contacts
77 sites in 13 countries.
77 sites in 13 countries
France16 sites
Study site
Antony, 92166
Study site
Beaumont, 63110
Study site
Bordeaux, 33000
Study site
Brive-la-Gaillarde, 19100
Study site
Cenon, 33150
Study site
Colombes, 92701
Study site
Créteil, 94010
Study site
Domont, 95330
Study site
Lille, 59037
Study site
Montauban, 82000
Study site
Montpellier, 34059
Study site
Muret, 31600
Study site
Nancy, 54045
Study site
Paris, 75009
Study site
Paris, 75020
Study site
Toulouse, 31059
Germany8 sites
Study site
Berlin, State of Berlin, 10117
Study site
Berlin, State of Berlin, 10249
Study site
Essen, North Rhine-Westphalia, 45257
Study site
Grevenbroich, North Rhine-Westphalia, 41515
Study site
Leverkusen, North Rhine-Westphalia, 51375
Study site
München, Bavaria, 80336
Study site
Rostock, Mecklenburg-Vorpommern, 18057
Study site
Wuppertal, North Rhine-Westphalia, 42103
Poland8 sites
Study site
Bialystok, 15-276
Study site
Krakow, 30-501
Study site
Lodz, 93-338
Study site
Lublin, 20-090
Study site
Owock, 05-400
Study site
Poznan, 61-701
Study site
Warsaw, 00-416
Study site
Warsaw, 00-909
South Africa8 sites
Study site
Bloemfontein, Free State, 9300
Study site
Cape Town, Western Cape, 7505
Study site
Cape Town, Western Cape
Study site
Durban, KwaZulu-Natal, 4001
Study site
Johannesburg, Gauteng, 1804
Study site
Johannesburg, Gauteng, 2132
Study site
Pretoria, Gauteng, 0001
Study site
Pretoria, Gauteng
United Kingdom7 sites
Study site
Birmingham, West Midlands, B4 6DH
Study site
Bristol, Avon, BS2 8HW
Study site
London, Greater London, SW10 9NH
Study site
London, Greater London, SW17 0QT
Study site
London, Greater London, WC1E 6AU
Study site
Nottingham, Nottinghamshire, NG5 1PB
Study site
Southampton, Hampshire, SO14 0YG
Hungary5 sites
Study site
Budapest, 1115
Study site
Budapest, H-1085
Study site
Eger, 3301
Study site
Győr, 9024
Study site
Kecskemét, 6000
Sweden5 sites
Study site
Gothenburg, 413 45
Study site
Linköping, 581 85
Study site
Lund, 221 85
Study site
Trollhättan, 461 85
Study site
Varberg, 432 81
Finland4 sites
Study site
Hämeenlinna, 13530
Study site
Helsinki, 00029
Study site
Joensuu, 80210
Study site
Kotka, 48210
Lithuania4 sites
Study site
Klaipėda, 92288
Study site
Vilnius, LT-04130
Study site
Vilnius, LT-2000
Study site
Vilnius, LT-2021
Denmark3 sites
Study site
Hvidovre, 2650
Study site
Odense C, DK-5000
Study site
Roskilde, DK-4000
Greece3 sites
Study site
Athens, Attica, 115 21
Study site
Athens, Attica, 11528
Study site
Dourouti-Ioannina, Ioannina, 45500
Italy3 sites
Study site
Pavia, 27100
Study site
Perugia, 06122
Study site
Trieste, 34137
Russia3 sites
Study site
Moscow, 107076
Study site
Moscow, 117049
Study site
Moscow, 117997
About this study
Official title: Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- Ofloxacin, Avelox (Moxifloxacin, BAY12-8039)
- Keywords
- Antibiotic treatment, Pelvic infection, Interventional study, Female
- Medical subject headings
- Pelvic Inflammatory Disease, Pelvic Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfloxacinDrug
Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
Avelox (Moxifloxacin, BAY12-8039)Drug
Moxifloxacin 400 mg po od for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: Ofloxacin |
| Arm 2 | Experimental | Not described Receives: Drug: Avelox (Moxifloxacin, BAY12-8039) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response 5 to 24 days after the last dose of study medication
Measured: 5 to 24 days after the last dose
Secondary outcomes (4)
Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication
Measured: visit 28 to 42 days after last dose
Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose
Measured: (Day 4-7) and at follow-up 28 to 42 days after last dose
Reduction from baseline in pain report at the different assessment visits
Measured: Over the entire trial period (overall)
Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up
Measured: Over the entire trial period (overall)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startApr 2003
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 749 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683865
- Sponsor's protocol ID
- 10995
- Acronym
- MAIDEN
- Status last verified
- Oct 2014
- First submitted
- 21 May 2008
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)
- ClinicalTrials.gov ID
- NCT00683865
- Acronym / sponsor ID
- MAIDEN / 10995
- Conditions
- Pelvic Inflammatory Disease
- Keywords
- Antibiotic treatment, Pelvic infection, Interventional study, Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 749 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Ofloxacin |
| Arm 2 | Experimental | Drug: Avelox (Moxifloxacin, BAY12-8039) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness;
- Adnexal tenderness on bimanual vaginal examination,
- Temperature > 38.0°C; - Elevated C-reactive protein value (CRP);
- Signed PIC/IC
Key exclusion criteria (2 listed)
- Pregnancy
- Abnormal lab values
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 |
|---|---|---|
| OfloxacinOfloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days | Drug | Arm 1 |
| Avelox (Moxifloxacin, BAY12-8039)Moxifloxacin 400 mg po od for 14 days | Drug | Arm 2 |
Primary outcome
Clinical response 5 to 24 days after the last dose of study medication
Time frame: 5 to 24 days after the last dose
4 secondary outcomes
Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication
Time frame: visit 28 to 42 days after last dose
Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose
Time frame: (Day 4-7) and at follow-up 28 to 42 days after last dose
Reduction from baseline in pain report at the different assessment visits
Time frame: Over the entire trial period (overall)
Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up
Time frame: Over the entire trial period (overall)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
Related trials for Pelvic Inflammatory Disease
Not yet recruitingPhase 4
ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery
Ulcerative Colitis (UC), Pouchitis
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Cervical Carcinoma, Endometrial Carcinoma
RecruitingPhase 1/2
Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Endometriosis, Adenomyosis
Not yet recruiting
Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
Cesarean Section, Surgical Site Infection
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.
Bayer Study Director study director
Bayer
77 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ofloxacin and Avelox (Moxifloxacin, BAY12-8039) in people with Pelvic Inflammatory Disease, run by Bayer at 77 sites in 13 countries.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in France, Germany, Poland, South Africa, United Kingdom and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical response 5 to 24 days after the last dose of study medication (time frame: 5 to 24 days after the last dose). 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 15 Oct 2014.