Clinical trial for efficacy of soy isoflavone in postmenopausal women

A 12 week, randomized, double-blind and placebo-controlled clinical trial to assess the efficacy and safety of soy isoflavone in postmenopausal women

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001737

Enrollment

Registered

2015-12-17

Start date

2010-04-03

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The participants enrolled in this study was assigned to 2 groups by double-blinde randomization

Isoflavone group: Isoflavone 35 mg/cap*2 *1 time/1day, 12 weeks Placebo group: placebo 2 cap*1 time/day, 12 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: ?last spontaneous menstrual bleeding>12 month ago, aged 45-60 years ?hot flushes continued for at least three month ?Kupperman index ranged 20 to 40 ?Serum follicle-stimulating hormone (FSH) levels >= 40 IU /ml. ?BMI ranging between 19.0 to 30 kg/m2 ?Written informed consent

Exclusion criteria

Exclusion criteria: ? women who have hysterectomy or chemotherapy ? women who have abnormal finding such as endometrial proliferation, endometrial cancer and uterine cervical cancer related condition ? women who have breast cancer related condition ? women who received hormone replacement therapy or selective estrogen receptor modulators (SERMS) within five years of enrollment ? women who vaginal bleeding, unknown cause within six month of enrollment ? Women who have heart, kidney and thyroid disease ? Women who have depression and schizophrenia ? women who received hormone replacement therapy or selective estrogen receptor modulators (SERMS) within three month of enrollment ? Patient with systolic blood pressure =170 mmHg and diastolic pressure =100 mmHg, or hypertensive person who take diuretics (170/100 mmHg, at the screening) ? who had uncontrolled bood glucose (IFG 180 mg/dl mmHg, at the screening) ? who had soy allergy ? who participated other clinical trial within 3 months prior to this study ? who are not considrered to be appropriate to particiapt on this study

Design outcomes

Primary

Measure	Time frame
Hot flushes score	—

Secondary

Measure	Time frame
Kupperman’s index;Menopause-specific quality of life;E2, FSH, LH, total estrogen, Total cholesterol, Triglyceride, LDL-Chol., HDL-Chol., Free Fatty Acid, NTx, CTx, Bone ALP, Osteocalcin, U-DPD;hs-CRP, sVCAM, sICAM;Adverse effects, Blood & urine, Blood pressure, Electrocardiogram	—

Countries

Korea, Republic of

Contacts

Public ContactHansongyi Lee

Kyung Hee University

flowerlhsy@hanmail.net

Outcome results