cyclic mastodynia and PMS
Conditions
Interventions
Product Code: VAC BNO 1095 10 mg (FCT)
Pharmaceutical Form: Film-coated tablet
CAS Number: 8000042219
Current Sponsor code: VAC BNO 1095
Other descriptive name: vitex agnus castus dry extract
Concentr
Sponsors
Bionorica SE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females aged 18 to 45 who have signed an ICF at screening visit S-2 at the latest. 2. Subject has a history of cyclic mastodynia and PMS 3. Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2. 4. At screening visit S-2 subject is reporting at least one physical PMS symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the COPE symptom list 5. 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 COPE symptom list 6. In both run-in cycles: 6A. VAS = 50 mm at least on one of the days of the late luteal phase 6B. Cyclic course of the mastodynia, i.e. VAS in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the VAS in the late luteal phase (maximum value of 5 daily recordings) 6C. PMS sum score resulting from COPE must be 20 or more in the late luteal phase (average of daily recordings documented on days -5 to -1) 6D. at least one physical PMS symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present 6E. PMS sum score resulting from COPE must not exceed 10 at day 4 of the menstruation 6F. PMS sum score resulting from COPE must not exceed 8 in the mid follicular phase (average of daily recordings documented on days 6 to 10) 7. Compliance for keeping detailed symptom records can be expected. 8. Subject provides a negative pregnancy test at study start (if of childbearing potential) and uses a double-barrier hormone-free medically acknowledged contraception during the whole course of study (condom with jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), or a hormone-free intra uterine device. 9. An unsuspicious breast USG/ mammogram not older than 12 months ruling out signs of malignancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Proof of PMDD according to DSM-IV criteria as defined by APA based on the findings as follows : A total of at least 5 premenstrual symptoms with at least one severe mood symptom must be present. The instrument used for retrospective assessment will be a questionnaire according to DSM-IV criteria. In addition, the symptoms - must have a history of 1-year duration - must seriously interfere with work, relationships or social activities - must not be an exacerbation of another disease 2. 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: o any treatment for mastodynia or premenstrual complaints o sexual hormones, combinations and inhibitors o pituitary hormones and their inhibitors o hypothalamic hormones o neuroleptics, antidepressants o serotonin-reuptake-inhibitors o prolactin-inhibitors or prolactin stimulating preparations o NSAIDs or any other analgetics including antirheumatics o spironolactone o androgens o gonadotrophin inhibitors o diuretics o danazol o psychotropic agents 3. Any psychiatric treatment before treatment start (visit S-2 up to visit V0) and within 12 months prior to visit S-2. 4. Medical history or presence of any of the following medical conditions/ diseases such as o Uncontrolled diabetes mellitus o Uncontrolled hypertension or any other uncontrolled disease or condition at the discretion of the investigator o Known hyperprolactinemia (> 50 ng/ml or > 1250 IU/ml) o Known hypo-/hyperthyreosis o Known hypo-/hyperparathyroidism o Known pituitary tumor including prolactinoma o Known chronic kidney disease o Known gastrointestinal, or liver diseases, such as: a. active peptic gastric ulcer b. malabsorption c. hepatitis o endometriosis o breast cancer, fibroadenoma, intraductal papilloma o suspicious non-verified finding on any breast ultrasound or mammograms in the past o galactorrhea of degree II or III o purulent or bloody nipple discharge o refractory and/or unverified breast skin- or nipple/areola lesions o pregnancy, lactation o wish for pregnancy o any surgery planned to take place during the trial including breast cyst puncture 5. Values of safety laboratory parameters outside normal ranges and clinically relevant as assessed by the investigator 6. Parallel participation in another clinical study, participation in another study within less than 6 weeks prior to study entry at S-2, or previous participation in the same study. 7. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history) 8. Evidence of an uncooperative attitude 9. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study. 10. Patients in custody by judicial or official order. 11. Patients who have difficulties in understanding the language in which the patient information is given. 12. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Identification of the optimal dosage of VAC BNO 1095 FCT for treatment of cyclic mastodynia and PMS To prove the efficacy of VAC BNO 1095 FCT in the treatment of cyclic mastodynia ;Secondary Objective: n.a.;Primary end point(s): Change in maximum severity of cyclic breast pain (cyclic mastodynia) from Baseline (late luteal phase of 2nd run-in cycle) to V3 (late luteal phase of the 3rd treatment cycle under study medication). The severity of cyclic breast pain will be self- assessed by the patient on a Visual Analogue Scale (VAS). | — |
Countries
Czech Republic
Outcome results
None listed