EstroG-100 on menopausal wome

Completed

Conditions: Menopausal symptoms
Urological and Genital Diseases
Menopause

Registration Number: ISRCTN95953457

Lead Sponsor: aturalendo Tech Co., Ltd (South Korea)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 64

Inclusion Criteria

1. Women aged between 42 and 70 years
2. Moderate or severe menopausal symptoms (score of greater than or equal to 20) identified by a simplified questionnaire with the Kupperman Menopause Index (KMI)
3. Eligibility was re-examined with the results of laboratory, mammogram, and pelvic ultrasound tests

Exclusion Criteria

1. Concurrent use of dietary supplement for menopause symptoms
2. Any suspicion of breast or endometrial malignancy
3. History of using oestrogen or progestin-containing products in past 3 months
4. Psychoactive drugs
5. Body mass index (BMI) greater than 40 kg/m^2
6. Irregular gynaecological bleeding 1 year after menopause
7. Hysterectomy
8. Uncontrolled hypertension
9. Thyroid disease
10. Diabetes mellitus
11. History of hormone-dependent (gynaecological) cancer
12. Drug and alcohol abuse
13. Mental disorder
14. Abnormality in renal and liver functions
15. Personal or family history of breast cancer in first degree relative
16. History of clotting disorder such as deep vein thrombosis (DVT)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean change in scores of self-scored Kupperman Menopause Index (KMI)<br>2. Mean change in scores of each symptom of the questionnaire from KMI<br>3. Mean change in scores of vaginal dryness<br><br>The KMI includes hot flash or cold sweat (vasomotor), numbness and tingling (paresthesia), trouble sleeping (insomnia), nervousness, feeling blue or depressed (melancholia), dizzy spells (vertigo), tired feelings (fatigue), rheumatic pain (arthralgia and myalgia), headaches, pounding of the heart (palpitation), and sensation of crawling on the skin (formication).

Secondary Outcome Measures