Vaginal Atrophy in Breast Cancer PatientsPhase 3NCT03740945
Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
A Phase 3 study testing Prasterone (DHEA) in people with Vaginal Atrophy in Breast Cancer Patients, run by EndoCeutics Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Vaginal Atrophy in Breast Cancer Patients
- What is being tested?
- Prasterone (DHEA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2018to 5 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main criteria:
- Natural, surgically- or treatment-induced postmenopausal women (non hysterectomized or hysterectomized) with breast cancer (stage 1 or 2) who is currently under treatment with an aromatase inhibitor and will remain on that treatment for the duration of the study.
- Women between 30 and 80 years of age
- Women having ≤5% of superficial cells on vaginal smear at baseline
- Women having a vaginal pH above 5 at baseline
- Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
Who cannot join
- Main criteria:
- Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
- The administration of any investigational drug within 30 days of screening visit
About this study
Official title: Effect of Intravaginal Prasterone (DHEA) on Moderate to Severe Symptoms of Vulvovaginal Atrophy Due to Menopause, in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer - (Placebo-Controlled, Double Blind and Randomized Phase III Study)
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.
- Being tested
- Placebo, Prasterone (DHEA)
- Keywords
- Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, Prasterone, DHEA, Intrarosa, Breast cancer, Aromatase inhibitor
- Medical subject headings
- Atrophic Vaginitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Daily administration of one placebo vaginal ovule at bedtime
Prasterone (DHEA)Drug
Also called Intrarosa
Daily administration of one prasterone vaginal ovule at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo vaginal ovule daily for 12 weeks Receives: Drug: Placebo |
| Prasterone | Experimental | Prasterone (DHEA) vaginal ovule daily for 12 weeks Receives: Drug: Prasterone (DHEA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 12 in the Percentage of Superficial Cells
Measured: 12 weeks
Change from Baseline to Week 12 in the Percentage of Parabasal Cells
Measured: 12 weeks
Change from Baseline to Week 12 in Vaginal pH
Measured: 12 weeks
Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS)
Measured: 12 weeks
Secondary outcomes (10)
Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start6 Nov 2018
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
Why it stopped: Business decision to not perform this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vaginal Atrophy in Breast Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoCeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Claude Labrie, M.D., Ph.D., Study chair, Endoceutics, Inc., Quebec, CanadaDavid F Archer, M.D., Principal investigator, Jones Institute, Norfolk VA 23507Sheryl Kingsberg, Ph.D., Principal investigator, MacDonald Women's Hospital, Cleveland, OH 44106 USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740945
- Sponsor's protocol ID
- ERC-260
- Status last verified
- Jul 2020
- First submitted
- 7 Nov 2018
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26291918Labrie 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.
PubMed 26597311Labrie 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.
PubMed 26517756Labrie 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.
PubMed 26731686Martel 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.
PubMed 26972555Montesino 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.
PubMed 26634942Archer 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.
PubMed 25734980Labrie 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.
PubMed 28640161
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravaginal Prasterone (DHEA) on Moderate to Severe Symptoms of Vulvovaginal Atrophy Due to Menopause, in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer - (Placebo-Controlled, Double Blind and Randomized Phase III Study)
- ClinicalTrials.gov ID
- NCT03740945
- Acronym / sponsor ID
- ERC-260
- Keywords
- Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, Prasterone, DHEA, Intrarosa, Breast cancer, Aromatase inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision to not perform this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EndoCeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo vaginal ovule daily for 12 weeks |
| Prasterone | Experimental | Drug: Prasterone (DHEA)Prasterone (DHEA) vaginal ovule daily for 12 weeks |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Natural, surgically- or treatment-induced postmenopausal women (non hysterectomized or hysterectomized) with breast cancer (stage 1 or 2) who is currently under treatment with an aromatase inhibitor and will remain on that treatment for the duration of the study.
- Women between 30 and 80 years of age
- Women having ≤5% of superficial cells on vaginal smear at baseline
- Women having a vaginal pH above 5 at baseline
- Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
Key exclusion criteria (3 listed)
- Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
- The administration of any investigational drug within 30 days of screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDaily administration of one placebo vaginal ovule at bedtime | Drug | Placebo |
| Prasterone (DHEA)Also: IntrarosaDaily administration of one prasterone vaginal ovule at bedtime | Drug | Prasterone |
Primary outcome
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
10 secondary outcomes
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
Time frame: 12 weeks
Change from Baseline to Week 12 on subjective arousal domain of FSFI
Time frame: 12 weeks
Change from Baseline to Week 12 on desire domain of FSFI
Time frame: 12 weeks
Change from Baseline to Week 12 on satisfaction domain of FSFI
Time frame: 12 weeks
Change from Baseline to Week 12 on orgasm domain of FSFI
Time frame: 12 weeks
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
Time frame: 12 weeks
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
Time frame: 12 weeks
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
Time frame: 12 weeks
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Results publication: PubMed 26291918Ke 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.
- Results publication: PubMed 26597311Labrie 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.
- Results publication: PubMed 26517756Labrie 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.
- Results publication: PubMed 26731686Labrie 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.
- Results publication: PubMed 26972555Martel 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.
- Results publication: PubMed 26634942Montesino 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.
- Results publication: PubMed 25734980Archer 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.
- Results publication: PubMed 28640161Labrie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Labrie, M.D., Ph.D. study chair
Endoceutics, Inc., Quebec, Canada
David F Archer, M.D. principal investigator
Jones Institute, Norfolk VA 23507
Sheryl Kingsberg, Ph.D. principal investigator
MacDonald Women's Hospital, Cleveland, OH 44106 USA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prasterone (DHEA) in people with Vaginal Atrophy in Breast Cancer Patients, run by EndoCeutics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 12 in the Percentage of Superficial Cells (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740945, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.