Premenstrual SyndromePhase 3NCT01870687
Efficacy and Safety of 20 mg (2 Tablets of 10mg)VAC BNO 1095 FCT on Cyclic Mastodynia and PMS
A Phase 3 study testing 20mg VAC BNO 1095 FCT in people with Premenstrual Syndrome and Mastodynia, run by Bionorica SE at 1 site in Germany.
Trial summary
The purpose of this study is to proof the efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 film-coated tablets in patients suffering from cyclic mastodynia and PMS (pre menstrual syndrome). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Mastodynia
- What is being tested?
- 20mg VAC BNO 1095 FCT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Oct 2014
- 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 18 to 45 Y with a history of cyclic mastodynia and PMS
- Stable cycle duration of 25 to 35 days.
- Subject is reporting at least one moderate or severe physical PMS symptom moderate and one psychic symptom, using the COPE symptom list
- Subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the COPE symptom list
- In both run-in cycles: Confirmation of cyclic mastodynia based on daily recordings of patient diary (VAS and COPE data)
- Subject provides a negative pregnancy test at study start and is willing to use a hormone-free medically acknowledged contraception methods with a PEARL-index < 1 % from enrolment
- Unsuspicious breast USG/mammogram not older than 12 months ruling out signs of malignancy
Who cannot join
- Hypersensitivity to the active substance or to the excipients of the IMP
- Proof of PMDD according to DSM IV criteria as defined by APA
- Intake of any of the following medications before treatment start and within 6 months prior to screening visit:
- hypothalamic hormones
- injectable contraceptives: 3-month injection
- Intake of any of the following medications (including herbal or homeopathic drugs) before treatment start and within 3 months prior to screening visit:
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- any treatment for mastodynia or premenstrual complaints
- sexual hormones, combinations and inhibitors
- pituitary hormones and their inhibitors
- dopamine-agonists and dopamine-antagonists
- neuroleptics, antidepressants (including serotonin- and serotonin-norepinephrine-reuptake-inhibitors)
- prolactin-inhibitors or prolactin stimulating preparations
- drug abuse or continuous intake of NSAIDs or any other analgetics including antirheumatics (up to 2 tablets of paracetamol 500 mg or equivalent per week are allowed)
- spironolactone
- gonadotrophin inhibitors
- diuretics
- danazol
- psychotropic agents
- Any psychiatric treatment before treatment start and within 12 months prior to screening visit
- Medical history or presence of any of the following medical conditions/ diseases before treatment start:
- Uncontrolled diabetes mellitus: Patients with known diabetes mellitus, who have a glycosylated haemoglobin (HbA1c) ≥ 7% as assessed at visit S-1
- Uncontrolled hypertension: Patients with a diastolic blood pressure >90mmHg at visit S-2
- Known cardiac insufficiency, coronary heart disease, valvular heart disease, cardiac arrhythmia, QT interval prolongation or other severe cardiac disease at visit S-2
- Known clinically significant organ or systemic diseases or any other relevant medical condition such that in the opinion of the investigator, the significance of the disease or condition will compromise the subject's participation in the study
- Known hyperprolactinemia (serum prolactin basal > 50 ng/ml or > 1050 mlU/L)
- Known hypo-/hyperthyreosis
- Known hypo-/hyperparathyroidism
- Known pituitary tumor including prolactinoma
- Known chronic kidney disease
- Known gastrointestinal, or liver diseases, such as:
- active peptic gastric ulcer ii. malabsorption iii. hepatitis
- endometriosis
- breast cancer, fibroadenoma, intraductal papilloma or other malignancy within the last 10 years
- suspicious non-verified finding on any breast ultrasound or mammograms in the past
- galactorrhea of degree II or III
- purulent or bloody nipple discharge
- refractory and/or unverified breast skin- or nipple/areola lesions
- pregnancy, lactation
- wish for pregnancy
- any surgery planned to take place during the trial including breast cyst puncture
- Values of safety laboratory parameters outside normal ranges and clinically relevant as assessed by the investigator at S-1
- At screening:TSH > 2.5 mU/L
- Patients who have difficulties in understanding the language in which the patient information is given
- Patients who are members of the staff of the study centre, staff of the sponsor or CRO, the investigator herself or close relatives of the investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
Private Doctor's office - Dr. Hannes Herold
Munich, Bavaria, 80802
About this study
Official title: Prospective, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Randomized Clinical Trial to Proof Efficacy and Safety of 20 mg (2 Tablets of 10 mg) VAC BNO 1095 FCT in Patients Suffering From Cyclic Mastodynia and PMS
The purpose of this study is to proof the efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 film-coated tablets in patients suffering from cyclic mastodynia and PMS (pre menstrual syndrome).
Read the detailed description
The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening at S-2 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.
At least 220 patients should be eligible for randomisation, 110 to each treatment group, of which 160 (80 per group) will be available for data evaluation.
- Conditions
- Premenstrual Syndrome, Mastodynia
- Being tested
- 20mg VAC BNO 1095 FCT, Placebo
- Keywords
- vitex agnus castus, clinical trial, cyclic mastodynia, PMS, prospective
- Medical subject headings
- Premenstrual Syndrome, Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20mg VAC BNO 1095 FCTDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| VAC BNO 1095 2x10 mg FCT | Experimental | VAC BNO 1095 2x10 mg FCT 2 tablets of verum in the morning, oral, 3 months treatment Receives: Drug: 20mg VAC BNO 1095 FCT |
| Placebo | Placebo comparator | 2 tablets in the morning, oral, 3 months treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum severity of cyclic breast pain
Maximum severity of cyclic breast pain after 3 months treatment under Investigational Medicinal Product (IMP). The severity of cyclic breast pain will be self-assessed by the patient on a Visual Analogue Scale (VAS).
Measured: after 3 months treatment under Investigational Medicinal Product (IMP).
Secondary outcomes (1)
Severity of cyclic breast pain and PMS symptoms
- Maximum severity of cyclic breast pain after 1 and 2 months treatment, respectively. The severity of cyclic breast pain will be self-assessed by the patient on a VAS
- Average severity of cyclic mastodynia, determined in the late luteal phase of each of the treatment cycles.
- Intensity of PMS assessed by means of a PMS diary (COPE = calendar of premenstrual experiences) during each of the treatment cycles
- Overall assessments of efficacy on cyclic mastodynia and PMS by patient and investigator at study end by a score ranging from 1 to 5
- Subgroup analysis: A. Patients with the waist circumference ≤ 90 cm B. Patients with the waist circumference > 90 cm. For both subgroups A. and B.: Maximum severity of cyclic breast pain after 3 months treatment under IMP. The severity of cyclic breast pain will be self-assessed by the patient on a VAS.
Measured: After 1, 2 and 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrzej Witek, MD PhD Prof., Study chairHannes Herold, Dr. med., Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870687
- Sponsor's protocol ID
- P-AG-E-4
- Other IDs
- 2012-005042-37
- Status last verified
- Sep 2016
- First submitted
- 16 May 2013
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Randomized Clinical Trial to Proof Efficacy and Safety of 20 mg (2 Tablets of 10 mg) VAC BNO 1095 FCT in Patients Suffering From Cyclic Mastodynia and PMS
- ClinicalTrials.gov ID
- NCT01870687
- Acronym / sponsor ID
- P-AG-E-4
- Conditions
- Premenstrual Syndrome, Mastodynia
- Keywords
- vitex agnus castus, clinical trial, cyclic mastodynia, PMS, prospective
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Bionorica SEIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Jun 2013 (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.
The purpose of this study is to proof the efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 film-coated tablets in patients suffering from cyclic mastodynia and PMS (pre menstrual syndrome).
Detailed description
The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening at S-2 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.
At least 220 patients should be eligible for randomisation, 110 to each treatment group, of which 160 (80 per group) will be available for data evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAC BNO 1095 2x10 mg FCT | Experimental | Drug: 20mg VAC BNO 1095 FCTVAC BNO 1095 2x10 mg FCT 2 tablets of verum in the morning, oral, 3 months treatment |
| Placebo | Placebo comparator | Drug: Placebo2 tablets in the morning, oral, 3 months treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females 18 to 45 Y with a history of cyclic mastodynia and PMS
- Stable cycle duration of 25 to 35 days.
- Subject is reporting at least one moderate or severe physical PMS symptom moderate and one psychic symptom, using the COPE symptom list
- Subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the COPE symptom list
- In both run-in cycles: Confirmation of cyclic mastodynia based on daily recordings of patient diary (VAS and COPE data)
Key exclusion criteria (44 listed)
- Hypersensitivity to the active substance or to the excipients of the IMP
- Proof of PMDD according to DSM IV criteria as defined by APA
- Intake of any of the following medications before treatment start and within 6 months prior to screening visit:
- Intake of any of the following medications (including herbal or homeopathic drugs) before treatment start and within 3 months prior to screening visit:
- Any psychiatric treatment before treatment start and within 12 months prior to screening visit
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 |
|---|---|---|
| 20mg VAC BNO 1095 FCT | Drug | VAC BNO 1095 2x10 mg FCT |
| Placebo | Drug | Placebo |
Primary outcome
Maximum severity of cyclic breast pain
Time frame: after 3 months treatment under Investigational Medicinal Product (IMP).
Maximum severity of cyclic breast pain after 3 months treatment under Investigational Medicinal Product (IMP). The severity of cyclic breast pain will be self-assessed by the patient on a Visual Analogue Scale (VAS).
1 secondary outcome
Severity of cyclic breast pain and PMS symptoms
Time frame: After 1, 2 and 3 months of treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
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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.
Andrzej Witek, MD PhD Prof. study chair
Hannes Herold, Dr. med. study chair
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 20mg VAC BNO 1095 FCT in people with Premenstrual Syndrome and Mastodynia, run by Bionorica SE at 1 site in Germany.
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 7 inclusion and 44 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: stopped early, as of the sponsor's last update on 14 Sep 2016. 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 Germany. 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 was stopped early. Results are not available in the source record.
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?
Maximum severity of cyclic breast pain (time frame: after 3 months treatment under Investigational Medicinal Product (IMP).). 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 14 Sep 2016.