Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome
Cyclic Mastodynia, Premenstrual Syndrome
About this trial
This is an interventional treatment trial for Cyclic Mastodynia
Eligibility Criteria
Inclusion Criteria:
- 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:
- 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.
Exclusion criteria:
- 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
- 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
Sites / Locations
- Gynekologicko-porodnická ambulance
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Active Comparator
Active Comparator
Placebo of VAC BNO 1095
10 mg VAC BNO 1095
20 mg VAC BNO 1095
1 tablet of placebo in the morning, 1 tablet of placebo in the evening
1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of placebo in the evening
1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of VAC BNO 1095 10 mg in the evening