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Business decision to not perform this study.
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| Name | Class |
|---|---|
| AMAG Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo vaginal ovule daily for 12 weeks |
|
| Prasterone | Experimental | Prasterone (DHEA) vaginal ovule daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Daily administration of one placebo vaginal ovule at bedtime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Week 12 in the Percentage of Superficial Cells | 12 weeks | |
| Change from Baseline to Week 12 in the Percentage of Parabasal Cells | 12 weeks | |
| Change from Baseline to Week 12 in Vaginal pH | 12 weeks | |
| Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome) | 12 weeks | |
| Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. |
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Inclusion Criteria:
Main criteria:
Exclusion Criteria:
Main criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claude Labrie, M.D., Ph.D. | Endoceutics, Inc., Quebec, Canada | Study Chair |
| David F Archer, M.D. | Jones Institute, Norfolk VA 23507 | Principal Investigator |
| Sheryl Kingsberg, Ph.D. | MacDonald Women's Hospital, Cleveland, OH 44106 USA | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26291918 | Result | Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration. J Steroid Biochem Mol Biol. 2015 Nov;154:186-96. doi: 10.1016/j.jsbmb.2015.08.016. Epub 2015 Aug 17. | |
| 26597311 |
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| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Prasterone (DHEA) |
| Drug |
Daily administration of one prasterone vaginal ovule at bedtime |
|
|
| 12 weeks |
| Change from Baseline to Week 12 on subjective arousal domain of FSFI | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. | 12 weeks |
| Change from Baseline to Week 12 on desire domain of FSFI | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. | 12 weeks |
| Change from Baseline to Week 12 on satisfaction domain of FSFI | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. | 12 weeks |
| Change from Baseline to Week 12 on orgasm domain of FSFI | Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor. | 12 weeks |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy. | 12 weeks |
| Result |
| Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23. |
| 26517756 | Result | Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner. Climacteric. 2015;18(6):817-25. doi: 10.3109/13697137.2015.1077508. Epub 2015 Oct 30. |
| 26731686 | Result | Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571. |
| 26972555 | Result | Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10. |
| 26634942 | Result | Montesino M, Labrie F, Archer DF, Zerhouni J, Cote I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6. |
| 25734980 | Result | Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428. |
| 28640161 | Result | Labrie F, Archer DF, Martel C, Vaillancourt M, Montesino M. Combined data of intravaginal prasterone against vulvovaginal atrophy of menopause. Menopause. 2017 Nov;24(11):1246-1256. doi: 10.1097/GME.0000000000000910. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |