Efficacy and safety of chaste tree extract with the name VAC BNO 1095 10 mg FCT (20 mg daily) on cyclic breast pain and premenstrual syndrome

Conditions: Cyclic mastodynia and PMS
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2012-005042-37-PL

Lead Sponsor: Bionorica SE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 280

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 at visit S-2
3. Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2 and during run in phase
4. At screening visit S-2 subject is reporting at least one physical PMS symptom (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 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 7 daily recordings) is less than 75 % of the VAS in the late luteal phase (maximum value of 7 daily recordings)
6C. At least one physical PMS symptom and one psychic symptom is present on at least one day of the late luteal phase.
6D. PMS sum score resulting from COPE in the mid follicular phase (sum score of all PMS sum scores across the seven-day phase) is less than 75 % of the PMS sum score resulting from COPE in the late luteal phase (sum score of all PMS sum scores across the seven-day phase)
7. Compliance for keeping detailed symptom records can be expected
8. Subject provides a negative pregnancy test at study start (S-2, V0 and V3 if of childbearing potential) and is willing to use one of the following hormone-free medically acknowledged contraception methods with a PEARL-index < 1 % from enrolment till onset of next menses after study termination:
• Double-barrier method, e.g. condom* AND occlusive cap (diaphragm or Portio cap or Lea Contraceptivum) with spermicidal foam/gel/film/cream/suppository (* A female condom and a male condom should not be used together as friction between the two can result in either product failing.), OR
• hormone-free intra uterine device (IUD) AND condom, OR
• hormone-free IUD AND sponge, OR
• hormone-free IUD AND spermicidal foam/gel/film/cream/suppository OR
• vasectomized partner OR
• sexual abstinence
Non childbearing potential group is defined for the intended patient as surgical sterilisation at least three months before the start of the study
9. An unsuspicious breast USG/mammogram not older than 12 months ruling out signs of malignancy is available (otherwise arrange breast USG prior to visit S-1, exceptionally prior to V0)

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 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Hypersensitivity to the active substance or to any of the excipients of the IMP at visit S-2
2. Proof of PMDD at visit S-2 according to DSM-IV criteria as defined by APA [American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders , 4th ed. Text Revision. Washington, DC: American Psychiatric Association, 2000] 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
3. 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:
• hypothalamic hormones
• injectable contraceptives: 3-month injection
4. Intake of any of the following medications (including herbal or homeopathic drugs) before treatment start (visit S-2 up to visit V0) and within 3 months prior to visit S 2 (with exception of hypothalamic hormones and 3-monthly injectable contraceptives: 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
• 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
5. Any psychiatric treatment before treatment start (visit S-2 up to visit V0) and within 12 months prior to visit S-2
6. 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 > 90 mmHg 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:
a. active peptic gastric ulcer
b. malabsorption
c. 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, l

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To prove the efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 FCT in the treatment of cyclic mastodynia.;Secondary Objective: not applicable;Primary end point(s): Maximum severity of cyclic breast pain (cyclic mastodynia) during the late luteal phase of the 3rd treatment cycle under Investigational Medicinal Product (IMP). The severity of cyclic breast pain will be self-assessed by the patient on a Visual Analogue Scale (VAS).;Timepoint(s) of evaluation of this end point: During the end (late luteal phase) of the 3rd treatment cycle

Secondary Outcome Measures

Name	Time	Method

Related Trials