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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estradiol 10 micrograms vaginal tablets | Active Comparator | One tablet intravaginally once daily for two weeks. Thereafter one tablet twice per week with at least a 3-days interval between treatments to maintain therapeutic response. |
|
| Promestriene 10mg./g vaginal cream | Active Comparator | One application once daily intravaginally for two weeks. Thereafter one application twice per week with at least a 3-days interval between treatments to maintain therapeutic response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol 10 MCG Vaginal Tablet [VAGIFEM] | Drug | To insert the tablets the patient must use the applicator provided in the way explained in the prospectus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vulvovaginal Symptoms | Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks | Change from Baseline, at week 4 and at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia. | Percentage of women that verify a relief of atrophic vaginitis dryness, dyspareunia, soreness and irritation symptoms in the questionnaires provided at Visit 1 and Visit 2 compared to intensity of those symptoms at screening visit. | Change from Baseline, at week 4 and at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Palacios | Madrid | 28009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34813408 | Derived | Palacios S, Ramirez M, Lilue M. Efficacy of low-dose vaginal 17beta-estradiol versus vaginal promestriene for vulvovaginal atrophy. Climacteric. 2022 Aug;25(4):383-387. doi: 10.1080/13697137.2021.1998436. Epub 2021 Nov 23. |
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| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D014622 | Vaginal Creams, Foams, and Jellies |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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A Prospective, monocentric, open-label, randomized, parallel-group study.
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| Promestriene Vaginal | Drug | To insert the cream the patient must use the applicator provided in the way explained in the prospectus. |
|
| Evaluation of changes in ph. | Percentage of women with changes in pH at Visit 1 and Visit 2 compared to Screening Visit. Comparison with the two groups | Change from Baseline, at week 4 and at week 12 |
| Evaluation of vaginal maturation index by Pap smear. | Percentage of woman with changes in vaginal maturation index by Pap smear at Visit 2 compared to Screening Pap smear and comparison between groups. | Change from Baseline, at week 4 and at week 12 |
| Evaluation of changes in soreness and irritation. | Percentage of women that verify a relief of atrophic vaginitis dryness, dyspareunia, soreness and irritation symptoms in the questionnaires provided at Visit 1 and Visit 2 compared to intensity of those symptoms at screening visit. | Change from Baseline, at week 4 and at week 12 |
| Occurrence of adverse events | Number of adverse events | Change from Baseline, at week 4 and at week 12 |
| Evaluation of endometrium thickness using vaginal ultrasound | Percentage of women with changes in endometrium thickness at Visit 2 compared to Screening Visit and comparison between groups | Change from Baseline, at week 4 and at week 12 |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D053566 | Feminine Hygiene Products |
| D004864 | Equipment and Supplies |