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| ID | Type | Description | Link |
|---|---|---|---|
| 475.622 | Registry Identifier | Opinion Number |
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To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conjugated Estrogen Group | Active Comparator | use of 1 gram per day |
|
| Promestriene Group | Active Comparator | use of 1 gram per day |
|
| Estriol Group | Active Comparator | use of 1 gram per day |
|
| Vaginal Moisturizer Cream | Placebo Comparator | use of 1 gram per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conjugated Estrogen | Drug | use of 1 gram per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the histopathological effects on endometrium after each treatment | Compare the histopathological results after treatment on each group and among each other | 48 days |
| Compare the endometrial thickness measured by ultrassound after each treatment | Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other | 48 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the changes of maturation index (Meisels Index) after each treatement | Compare the changes on Meisels Index after each treatment and among each other | 48 days |
| Evaluate the changes on climacteric complaints after each treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23985562 | Result | Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2. | |
| 37431855 | Derived | Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2. |
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| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| D056887 | Pelvic Organ Prolapse |
| D004714 | Endometrial Hyperplasia |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004966 | Estrogens, Conjugated (USP) |
| C013657 | promestriene |
| D004964 | Estriol |
| ID | Term |
|---|---|
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
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| Promestriene | Drug | use of 1 gram per day |
|
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| Estriol | Drug | use of 1 gram per day |
|
|
| Vaginal Moisturizer - Cream | Drug | use of 1 gram per day |
|
|
Compare the changes on systemic and genital complaints after each treatment, and among each other
| 48 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |