Menopause Clinical Trial
Official title:
The Effect of Low Dose Combined Hormone Therapy (Estradiol And Norethindrone Acetate) on Serum CRP Levels and Life Quality in Natural Menopause Women
NCT number | NCT04424173 |
Other study ID # | 2007/25 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2007 |
Est. completion date | August 30, 2008 |
Verified date | June 2020 |
Source | Karadeniz Technical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to assess the effect of low dose combined estradiol and norethindrone acetate hormone therapy on serum CRP levels and life quality in natural menopause women. 45 natural menopause women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynaecology for 1 year and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms involved in this study. The serum CRP levels and vasomotor symptoms scores graded according to Blatt-Kupperman Index and life quality scores according to Menopause-Specific Quality of Life Questionnaire (MENQOL) in Turkish were recorded before and after (3 months later) low dose hormone treatment (1 mg Estradiol and 0.5 mg Norethindrone acetate).
Status | Completed |
Enrollment | 45 |
Est. completion date | August 30, 2008 |
Est. primary completion date | August 1, 2008 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 45 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Accepting consent to participate in the research and signing the form; - Postmenopausal women 45-55 years old - not having had menstruation for the past 6 months; - Hormone results compatible with menopause (FSH> 20 milli-International unit(mIU) / mL, E2 <20 mIU / mL) and presence of vasomotor and/or menopausal symptoms (moderate to severe); - no systemic disease (Diabetes, hypertension, hyperlipidemia, ischemic heart disease), or no infectious disease in the past 2 weeks; - not taking any hormone therapy or medication for at least 2 months; - no contraindications for hormone therapy in routine menopause evaluation; - Willingness to take hormone therapy - No smoking. Exclusion Criteria: - Any systemic disease (DM, HT, hyperlipidemia, ischemic heart disease) presence - Smoking - Contraindications for hormone therapy - Failure to follow-up - Inability to complete three months of hormone therapy - Stopping hormone therapy due to vaginal bleeding during hormone therapy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karadeniz Technical University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood was drawn for basal CRP from all patients | The patients who were evaluated for the Blatt-Kupperman index and MENQOL questionnaire were given three months of treatment to the patient, which included 1.03 mg , Estradiol hemihydrate and 0.5 mg Norethindrone acetate | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04553029 -
A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
|
||
Completed |
NCT03672513 -
Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
|
N/A | |
Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04210583 -
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
|
N/A | |
Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
Completed |
NCT05617287 -
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
|
N/A | |
Recruiting |
NCT05180266 -
Therapeutic Touch and Music in The Menopausal Period
|
N/A | |
Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
Completed |
NCT03363997 -
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
|
Phase 1 | |
Not yet recruiting |
NCT04728126 -
Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
|
||
Not yet recruiting |
NCT04724135 -
Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
|
||
Completed |
NCT02274571 -
Raising Insulin Sensitivity in Post Menopause
|
Early Phase 1 | |
Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
Completed |
NCT02253173 -
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
Recruiting |
NCT01488903 -
A Cohort Research of Genetic Susceptibility for Common Obesity in Women
|
N/A | |
Terminated |
NCT01633814 -
Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women
|
N/A | |
Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A |