A Phase 3 interventional study of Placebo and Prasterone (DHEA) in Vaginal Atrophy in Breast Cancer Patients, sponsored by EndoCeutics Inc.. Withdrawn. Open to female participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-31.
Sponsored by EndoCeutics Inc. · Phase 3, Interventional, and Treatment
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.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
Browse Atrophic Vaginitis studies →EndoCeutics Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Main criteria:
Exclusion Criteria:
Main criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo vaginal ovule daily for 12 weeks
Drug: Placebo
Prasterone (DHEA) vaginal ovule daily for 12 weeks
Drug: Prasterone (DHEA)
Daily administration of one placebo vaginal ovule at bedtime
Daily administration of one prasterone vaginal ovule at bedtime
Also known as: Intrarosa
Change from Baseline to Week 12 in the Percentage of Superficial Cells
Time frame: 12 weeks
Change from Baseline to Week 12 in the Percentage of Parabasal Cells
Time frame: 12 weeks
Change from Baseline to Week 12 in Vaginal pH
Time frame: 12 weeks
Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS)
Time frame: 12 weeks
Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
Ran from Nov 2018 to primary completion in Dec 2019, 12 months.
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This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dehydroepiandrosterone
EndoCeutics Inc.