The Use of Pycnogenol® to Alleviate Menopausal Symptoms I... | NCT03704454

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A - PYC & Placebo	Experimental	50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks	Dietary Supplement: 50 mg PYC and then placebo
Group B - PYC & Placebo	Experimental	100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks	Dietary Supplement: 100 mg PYC and then placebo
Group C - Placebo & PYC	Experimental	Placebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks	Dietary Supplement: Placebo and then 50 mg PYC
Group D - Placebo & PYC	Experimental	Placebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks	Dietary Supplement: Placebo and then 100 mg PYC

Name	Type	Description	Arm Group Labels	Other Names
50 mg PYC and then placebo	Dietary Supplement	4 weeks on PYC, then 4 weeks on placebo	Group A - PYC & Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Menopause Rating Scale (MRS)	The MRS will be used to evaluate the efficacy of PYC in decreasing menopausal symptoms as compared to placebo. The difference-from-baseline (DFB) score will be calculated by taking the composite MRS score at 10 weeks and 12 weeks compared to the MRS score at baseline to determine whether or not PYC reduces symptoms, if the effects last beyond actively taking PYC, and if so, how long. The purpose of multiple time point assessments is two-fold: first, some patients will be taking placebo and some will be taking active drug in the first month, and vice versa during the second month. Therefore, an assessment needs to be done at each timepoint, weeks 4 and 8. Second, we are interested in understanding how long the symptoms management may last without actively taking drug, which accounts for the 10 week and 12 week timepoints.	The MRS will be administered at baseline, after 4 weeks, after 8 weeks, 2 week follow-up (10 weeks), and 1 month follow up (12 weeks) with the intention of calculating DFB score at each time point.

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Meg Christ	Contact	503-413-8199		mchrist@lhs.org
Leslie Sorenson	Contact	503-413-8199		lmsorens@lhs.org

Name	Affiliation	Role
Reza Antoszewska, NP-C	Legacy Health	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Legacy Mt. Hood Medical Center	Recruiting	Gresham	Oregon	97030	United States

ID	Term
D008595	Menorrhagia

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008599	Menstruation Disturbances