Who is sponsoring NCT01870687?

NCT01870687 is sponsored by Bionorica SE.

What condition does NCT01870687 study?

NCT01870687 studies Premenstrual Syndrome, Mastodynia.

What drugs are being tested in NCT01870687?

Interventions: 20mg VAC BNO 1095 FCT, Placebo.

What is the status of NCT01870687?

NCT01870687 is currently TERMINATED.

Last reviewed 2016-09-12 · How we verify

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

NCT01870687 Phase 3 TERMINATED

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).

Details

Lead sponsor	Bionorica SE
Phase	Phase 3
Status	TERMINATED
Enrolment	96
Start date	2013-06
Completion	2014-10

Conditions

Premenstrual Syndrome
Mastodynia

Interventions

20mg VAC BNO 1095 FCT
Placebo

Primary outcomes

Maximum severity of cyclic breast pain — 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).

Countries

Germany