Clinical trial NCT04424108: Hormone Therapy on Serum Ischemia Modified Albumin in Menopausal Women
Official title: The Effect of Hormone Therapy on Serum Ischemia Modified Albumin Levels in Surgical Menopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hormone Therapy Induced Morphologic Change
Surgical Menopause
Keywords: IMA
menopause
hormone therapy
cardiovascular risk
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Within 10 months of the study period, estradiol hemihydrate for all patients who underwent TAH + BSO for gynecology and obstetrics in our clinic and evaluated with the diagnosis of surgical menopause in the postoperative period (6th week) was prescribed. These cases were evaluated in terms of inclusion and exclusion criteria after they were determined to be volunteers to participate in the study.

Brief summary: Women suffer from cardiovascular diseases 10 years later than men, therefore female sex has been considered as a 'protective factor'. However, the risk of cardiovascular disease in women increases rapidly after menopause and the declining levels of endogenous estrogen is thought to be the causative factor. Furthermore, Postmenopausal hormone therapy (HT) decreases the severity and intensity of menopausal symptoms and improves women's quality of life. Until the last 10 years, based on the results of observational studies, postmenopausal HT may protect women against cardiovascular events and decrease the risk of coronary artery disease by 35-50%. However, recent randomized primary and secondary prevention trials did not support the cardioprotective effect of HT.

The aim of this study is to assess the effect of hormone therapy on serum ischemia modified albumin (IMA) levels. Thirty surgical menopausal women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynecology during 1-year period and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms were enrolled for this prospective study. The serum İMA levels were recorded before and after (3 months, 6 months, 12 months later) hormone treatment (2 mg Estradiol Hemihidrat).


Eligibility criteria: Inclusion Criteria:

* accepting consent to participate in the trial and signing the form
* Surgical menopausal women aged 45-55 (having TAH + BSO for benign reasons)
* Presence of vasomotor or menopausal symptoms (moderate to severe);
* no systemic disease or infectious disease in the past 2 weeks
* Not taking any other hormone therapy or medication until postoperative 6th week;
* no contraindications for hormone therapy in routine menopause evaluation;
* Willingness to take hormone therapy
* No smoking.

Exclusion Criteria:

* Any systemic disease presence
* Smoking
* Contraindications for hormone therapy
* Failure to follow-up
* Inability to complete three months of hormone therapy
* quitting hormone therapy for other medical reasons during hormone therapy
* Cases reported as preinvasive and invasive genital tumors as a result of TAH + BSO
* Cases reported as suspicious findings in the mammography report

Primary outcomes:
measure: Measuring serum ischemia-modified albumin (IMA) level
timeFrame: 12 months
measure: Hormone therapy usage
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: