Flaxseed Lignan (Brevail)

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions
Polycystic Ovarian Syndrome
Interventions
DRUG

Birth control

In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H\&P as well as repeat ultrasound and blood tests.

DRUG

Birth control plus Brevail

In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H\&P as well as repeat ultrasound and blood tests.

Trial Locations (1)

66160

The University of Kansas Medical Center, Kansas City

All Listed Sponsors
lead

University of Kansas Medical Center

OTHER

NCT01396369 - Flaxseed Lignan (Brevail) | Biotech Hunter | Biotech Hunter