Cyclic MastodyniaPhase 3NCT01309113
Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome
A Phase 3 study testing VAC BNO 1095 film coated tablets in people with Cyclic Mastodynia and Premenstrual Syndrome, run by Bionorica SE at 1 site in Czechia.
Trial summary
Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180 patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are expected to complete the study per… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cyclic Mastodynia, Premenstrual Syndrome
- What is being tested?
- VAC BNO 1095 film coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2011to Nov 2012
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged 18 to 45 who have signed an Informed Consent Form (ICF) at screening visit S-2 (screening visit -2) at the latest.
- Subject has a history of cyclic mastodynia and premenstrual syndrome
- Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2.
- At screening visit S-2 subject is reporting at least one physical premenstrual syndrome symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list
- At screening visit S-2 subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list
- In both run-in cycles:
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- Visual analog scale greater or equal 50 mm at least on one of the days of the late luteal phase
- Cyclic course of the mastodynia, i.e. visual analog scale in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the visual analog scale in the late luteal phase (maximum value of 5 daily recordings)
- Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must be 20 or more in the late luteal phase (average of daily recordings documented on days -5 to -1)
- At least one physical premenstrual syndrome symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present
- Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 10 at day 4 of the menstruation
- Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 8 in the mid follicular phase (average of daily recordings documented on days 6 to 10)
- Note: "Late luteal phase" is defined as days -5 to -1 (5 days prior to the onset of menses) while "mid follicular phase" is defined as days 6 to 10 after the onset of menses.
Who cannot join
- Pre- Menstrual Dysphoric Disorder
- Intake of any of the following medications before treatment start (visit S-2 up to visit V0) and within 6 months prior to visit S-2:
- Any treatment for mastodynia or premenstrual complaints
- Sexual hormones, combinations and inhibitors
- Pituitary hormones and their inhibitors
- Hypothalamic hormones
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- Neuroleptics, antidepressants
- Serotonin-re-uptake-inhibitors
- Prolactin-inhibitors or prolactin stimulating preparations
- Non Steroidal Anti-Inflammatory Drugs (NSAIDs) or any other analgetics including antirheumatics
- Spironolactone
- Androgens
- Gonadotrophin inhibitors
- Diuretics
- Danazol
- Psychotropic agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Comparison of VAC BNO 1095 Film Coated Tablets With Placebo to Identify Dose Dependent Effects in Patients Suffering From Cyclic Mastodynia and Premenstrual Syndrome
Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180 patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are expected to complete the study per protocol.
Study objectives:
Read more
Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for treatment of cyclic mastodynia and premenstrual syndrome.
To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic mastodynia.
Dose regimen:
Group 1: VAC BNO 1095 1x10 mg:
1 tablet of verum in the morning, 1 placebo tablet in the evening
Group 2: VAC BNO 1095 2x10 mg:
1 tablet of verum in the morning, 1 tablet of verum in the evening
Group 3: Placebo:
1 tablet placebo in the morning, 1 tablet placebo in the evening
The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening further visits are scheduled after the end of each of the first and second run-in cycle, and after the first, second and third treatment cycle, respectively.
Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of menstruation number n, with exception of the first screening visit which can be performed at any time prior to the first run-in cycle. Subsequently the time between the first study visit and the onset of the first run-in cycle menses T shall be added to the overall study duration.
In case that the next menstruation does not commence as expected, the patient should contact her investigator immediately in order to schedule a new appointment, approximately on the actual day 3 of the menses.
- Conditions
- Cyclic Mastodynia, Premenstrual Syndrome
- Being tested
- VAC BNO 1095 film coated tablets
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAC BNO 1095 film coated tabletsDrug
3 dosages: Placebo, 10 mg of VAC BNO 1095 once daily in the morning, 10 mg of VAC BNO 1095 twice daily in the morning and in the evening
| Study group | Role | What they receive |
|---|---|---|
| Placebo of VAC BNO 1095 | Placebo comparator | 1 tablet of placebo in the morning, 1 tablet of placebo in the evening Receives: Drug: VAC BNO 1095 film coated tablets |
| 10 mg VAC BNO 1095 | Active comparator | 1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of placebo in the evening Receives: Drug: VAC BNO 1095 film coated tablets |
| 20 mg VAC BNO 1095 | Active comparator | 1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of VAC BNO 1095 10 mg in the evening Receives: Drug: VAC BNO 1095 film coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum severity of cyclic breast pain from baseline to visit 3 evaluated by visual analog scales
Measured: Daily from the first day of first menstruation to the last study visit (22 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclic MastodyniaStudies of the same condition, open and under way.
- 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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karel Raus, MD, Study chair, PHAMOS Central and Eastern Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309113
- Sponsor's protocol ID
- P-AG-E-3
- Status last verified
- Jul 2013
- First submitted
- 23 Feb 2011
- Last updated
- 9 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Comparison of VAC BNO 1095 Film Coated Tablets With Placebo to Identify Dose Dependent Effects in Patients Suffering From Cyclic Mastodynia and Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT01309113
- Acronym / sponsor ID
- P-AG-E-3
- Conditions
- Cyclic Mastodynia, Premenstrual Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Bionorica SEIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 4 Mar 2011 (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.
Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180 patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are expected to complete the study per protocol.
Study objectives:
Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for treatment of cyclic mastodynia and premenstrual syndrome.
To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic mastodynia.
Dose regimen:
Group 1: VAC BNO 1095 1x10 mg:
1 tablet of verum in the morning, 1 placebo tablet in the evening
Group 2: VAC BNO 1095 2x10 mg:
1 tablet of verum in the morning, 1 tablet of verum in the evening
Group 3: Placebo:
1 tablet placebo in the morning, 1 tablet placebo in the evening
The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening further visits are scheduled after the end of each of the first and second run-in cycle, and after the first, second and third treatment cycle, respectively.
Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of menstruation number n, with exception of the first screening visit which can be performed at any time prior to the first run-in cycle. Subsequently the time between the first study visit and the onset of the first run-in cycle menses T shall be added to the overall study duration.
In case that the next menstruation does not commence as expected, the patient should contact her investigator immediately in order to schedule a new appointment, approximately on the actual day 3 of the menses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo of VAC BNO 1095 | Placebo comparator | Drug: VAC BNO 1095 film coated tablets1 tablet of placebo in the morning, 1 tablet of placebo in the evening |
| 10 mg VAC BNO 1095 | Active comparator | Drug: VAC BNO 1095 film coated tablets1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of placebo in the evening |
| 20 mg VAC BNO 1095 | Active comparator | Drug: VAC BNO 1095 film coated tablets1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of VAC BNO 1095 10 mg in the evening |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Females aged 18 to 45 who have signed an Informed Consent Form (ICF) at screening visit S-2 (screening visit -2) at the latest.
- Subject has a history of cyclic mastodynia and premenstrual syndrome
- Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2.
- At screening visit S-2 subject is reporting at least one physical premenstrual syndrome symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list
- At screening visit S-2 subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list
Key exclusion criteria (16 listed)
- Pre- Menstrual Dysphoric Disorder
- Intake of any of the following medications before treatment start (visit S-2 up to visit V0) and within 6 months prior to visit S-2:
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 |
|---|---|---|
| VAC BNO 1095 film coated tablets3 dosages: Placebo, 10 mg of VAC BNO 1095 once daily in the morning, 10 mg of VAC BNO 1095 twice daily in the morning and in the evening | Drug | 10 mg VAC BNO 1095, 20 mg VAC BNO 1095, Placebo of VAC BNO 1095 |
Primary outcome
Change in maximum severity of cyclic breast pain from baseline to visit 3 evaluated by visual analog scales
Time frame: Daily from the first day of first menstruation to the last study visit (22 weeks)
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 9 Jul 2013.
Related trials for Cyclic Mastodynia
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Study on the Effects of Acupuncture in Patients with Cyclic Mastalgia
Breast Pain
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.
Karel Raus, MD study chair
PHAMOS Central and Eastern Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VAC BNO 1095 film coated tablets in people with Cyclic Mastodynia and Premenstrual Syndrome, run by Bionorica SE at 1 site in Czechia.
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 13 inclusion and 16 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 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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. Some participants in this study may receive a placebo. 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?
Change in maximum severity of cyclic breast pain from baseline to visit 3 evaluated by visual analog scales (time frame: Daily from the first day of first menstruation to the last study visit (22 weeks)). 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 9 Jul 2013.