Efficacy and Safety of 20 mg (2 Tablets of 10mg)VAC BNO 1095 FCT on Cyclic Mastodynia and PMS

NCT01870687 | Terminated Phase 3

• 2 other identifiers: P-AG-E-42012-005042-37
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Premenstrual Syndrome; Mastodynia

Keywords

vitex agnus castus; clinical trial; cyclic mastodynia; PMS; prospective

Outcome Measures

Primary Outcomes (1)

• 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).

  after 3 months treatment under Investigational Medicinal Product (IMP).

Secondary Outcomes (1)

• Severity of cyclic breast pain and PMS symptoms

  After 1, 2 and 3 months of treatment

Study Arms (2)

VAC BNO 1095 2x10 mg FCT

EXPERIMENTAL

VAC BNO 1095 2x10 mg FCT 2 tablets of verum in the morning, oral, 3 months treatment

Drug: 20mg VAC BNO 1095 FCT

Placebo

PLACEBO COMPARATOR

2 tablets in the morning, oral, 3 months treatment

Drug: Placebo

Interventions

20mg VAC BNO 1095 FCT DRUG

VAC BNO 1095 2x10 mg FCT

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Bionorica SE: lead

Study Sites (1)

Private Doctor's office - Dr. Hannes Herold

Munich, Bavaria, 80802, Germany

Location

MeSH Terms

Conditions

Premenstrual Syndrome; Mastodynia

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Andrzej Witek, MD PhD Prof.

  STUDY CHAIR

• Hannes Herold, Dr. med.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

DE (1)