Postmenopausal atrophic vaginitis
Conditions
Interventions
A randomized clinical trial will be carried out with 80 women, with single blinding (only of the research participant), with the purpose of comparing two groups, one group using a levonorgestrel 52 mg
only the physician performing the insertion will know this information. The difference between the two IUDs is the amount of hormone each contains. The 52mg IUD is already approved for endometrial pro
Sponsors
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Eligibility
Sex/Gender
Female
Age
48 Years to No maximum
Inclusion criteria
Inclusion criteria: Postmenopausal patients or those transitioning to menopause; aged 48 or over; with Follicle-Stimulating Hormone FSH dosage greater than or equal to 25; with indication for hormonal therapy; who have a uterus; no contraindications to the use of Intrauterine Devices; with a mammogram no more than 1 year ago classified as Breast Imaging Reporting and Data System (BIRADS) 1/2 or 3
Exclusion criteria
Exclusion criteria: Previous use of Hormone Therapy; refusal to participate in the study; Endometrial line greater than or equal to 5 mm in women with more than one year since the last menstruation (post-menopause); abnormal uterine bleeding of structural cause (polyp, leiomyoma, adenomyosis, suspected endometrial malignant neoplasm) in women in the menopausal transition; contraindications to the use of Hormone Therapy (breast cancer, endometrial cancer, hormone-dependent ovarian cancer, history of stroke, history of ischemic heart disease, active liver disease, thrombosis, or acquired or hereditary thrombophilia, porphyria, meningioma); uterine malformations, intracavitary changes of the uterus; patient under investigation for hormone-dependent neoplasia or precursor lesion during the study follow-up; personal history of thromboembolism or diagnosis of thrombophilia; personal history of angina, stroke or myocardial infarction; active liver disease; hypersensitivity to the components of the medications used in the study; porphyria; neurological or psychiatric diseases that make it impossible to follow the study instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exepected outcome 1 - We hope that there will be no significant thickening of the endometrium as verified by transvaginal ultrasound. If the endometrial line is greater than or equal to 8 mm, an endometrial biopsy will be performed.;Expected outcome 2 - We hope that endometrial hyperplasia with atypia will not occur. Therefore, we will perform endometrial biopsies in women with an endometrial line greater than or equal to 8 mm, or in women with heavy and persistent bleeding after intrauterine device insertion. Endometrial biopsies will also be performed every 12 months after device insertion, regardless of the endometrial line. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 3 - We will assess whether there has been a change in menopausal symptoms using the Menopause Rating Scale (MRS);Expected outcome 4 - We will assess whether there has been a change in function through the Female Sexual Function Index (FSFI) questionnaire ;Expected outcome 5 - We will assess whether there has been a change in quality of life through the Women's Health Questionnaire (WHQ);Expected outcome 6 - We will assess whether there has been a change in the menstrual pattern using the questionnaire for quantitative measurement of uterine bleeding (PBAC - Pictorial Blood Assessment Chart), which is a visual method used to assess menstrual blood loss in a semi-quantitative way | — |
Countries
Brazil
Contacts
Public ContactLuiz Francisco Baccaro
Universidade Estadual de Campinas
Outcome results
None listed