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The study aims to evaluate the outcomes of different estrogen therapy regimens in patients with amenorrhea who face prolonged periods of hypoestrogenism.
The primary objective is to compare the outcomes on bone mass of different therapeutic regimens and identify more favorable. For this purpose, densitometry parameters such as BMD, T-score and Z-score at the level of the lumbar spine, femur and entire skeleton will be considered, comparing a bone densitometry (DXA technique, Dual X-ray Absorptiometry) Baseline with one carried out after at least one year of therapy. The secondary objective of the study is to assess other systemic/metabolic implications of the different therapies.
The present retrospective monocentric observational study involves the recruitment of patients afferite at the U.O. of Gynecology and Physiopathology of Human Reproduction in the time interval between 2011 and 2020 in condition of amenorrhea greater than 6 months, Aged between 15 and 39 at the time of first visit.
Patients will be asked to participate in this study during the outpatient follow-up visit.
The study will involve data collection through consultation of health records.
The objectives of the study will therefore be achieved by analysing the following parameters, which can be fully deduced from the medical records of the subjects in the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A | Natural estrogen (estradiol or valerate estradiol) administered transdermically | ||
| GROUP B | Natural estrogen administered orally | ||
| GROUP C | Etinil-estradiol administered orally | ||
| GROUP D | No therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | The objectives of the study will be achieved by analysing the following parameters: Collection of anamnestic (eating habits and sports, pathologies of importance, medication intake, previous surgical interventions, smoking habit, gynecological history). | Until the end of the study (1 year) |
| Primary Outcome Measure | The objectives of the study will be achieved by analysing the following parameters: Physical examination: calculation of BMI (weight Kg/(height meters * height in meters), blood pressure (mm Hg) | Until the end of the study (1 year) |
| Primary Outcome Measure | The objectives of the study will be achieved by analysing the following parameters: Transvaginal or transabdominal pelvic ultrasound (Uterus measures mm; endometrium thickness mm; ovary size volume cc and mesures mm) | Until the end of the study (1 year) |
| Primary Outcome Measure | The objectives of the study will be achieved by analysing the following parameters: Lumbar, femoral, total body dual-energy x-ray absorptiometry (DXA): BMD (g/cm2); T score e Z score. | Until the end of the study (1 year) |
| Primary Outcome Measure | Blood tests: hemoglobin (g/gl), hematocrit (%),red blood cells (million/µl), Platelets (x1000/ µl), Glucose (mg/dl), Alt (U/L), Ast (U/L), triglycerides (mg/dl), Total cholesterol (mg/dl), HDL Cholesterol (mg/dl), LH (mU/ml), FSH (mU/ml), Testosteron (ng/ml), Proladctin ( ng/ml), Estradiol (pg/ml); Urinalysis: PH, proteins(mg/dl) Glucose (mg/dl), Red blood cells (num/microL), Leukocytes | Until the end of the study (1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| GAGs and Ferriman Score | For Acne: The GAGS divides the face (forehead, each cheek, nose, and chin), chest, and back into six areas, and the severity in each zone is then assessed on a scale of 0 to 4 (0, no lesions; 1, comedones; 2, papules; 3, pustules; and 4, nodules. | Until the end of the study (1 year) |
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Inclusion criteria:
Exclusion criteria: No exclusion criteria are provided.
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The present retrospective observational study, monocentric, involves the recruitment of patients who have presented themselves to the U.O. of Gynecology and Pathophysiology of Human Reproduction in the time interval between 2011 and 2020 in condition of amenorrhea above 6 months, Aged between 15 and 39 at the time of first visit. Patients will be asked to participate in this study during the outpatient follow-up visit.
The study will involve data collection through consultation of health records.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria C Meriggiola, MD | Contact | 0512144394 | +39 | cristina.meriggiola@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria C Meriggiola, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero -Univeristaria di Bologna | Recruiting | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| GAGs and Ferriman Score |
For Hirsutism: The Ferriman-Gallwey is widely used to evaluate and quantify hirsutism in women. The method incorporates nine body regions (excludes legs and forearms) for the assessment of hair growth, rated from 0 (no growth of terminal hair) to 4 (extensive hair growth) in each of the nine locations. The total score therefore can range from 0 to 36 and a score of > 8 is considered a sign of androgen excess in Caucasian women. A score of 8 -15 indicates mild hirsutism and >15 indicates moderate or severe hirsutism. For other ethnic groups, the amount of hair expected for that ethnicity should be considered. |
| Until the end of the study (1 year) |