DHEA Against Vaginal Atrophy - Safety Study of 12 Months

Study Description

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Brief Summary:

The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.

Condition or disease	Intervention/treatment	Phase
Vaginal Atrophy	Drug: DHEA	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	530 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Study Start Date :	December 2010
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	December 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: DHEA; 0.5% DHEA (intravaginal)	Drug: DHEA; Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.; Other Name: Prasterone, Dehydroepiandrosterone, Vaginorm

Outcome Measures

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Primary Outcome Measures :

1. Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium [ Time Frame: Baseline and Week 52 (or discontinuation) ]
   The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.
2. Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels [ Time Frame: Baseline and Week 52 ]
   The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.

Secondary Outcome Measures :

1. Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). [ Time Frame: Baseline and Week 52 ]
   The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
2. Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). [ Time Frame: Baseline and Week 52 ]
   The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
3. Change From Baseline to Week 52 of Vaginal pH. [ Time Frame: Baseline and Week 52 ]
   A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
4. Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia [ Time Frame: Baseline and Week 52 ]
   The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
5. Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness [ Time Frame: Baseline and Week 52 ]
   The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
6. Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching [ Time Frame: Baseline and Week 52 ]
   The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

• Postmenopausal women (non-hysterectomized)
• Women between 40 and 75 years of age.
• Willing to participate in the study and sign an informed consent.
• Women who have self-identified symptom(s) of vaginal atrophy.
• Willing to have endometrial biopsy at screening and end of study (Week 52).

Main Exclusion Criteria:

• Undiagnosed abnormal genital bleeding.
• Hypertension equal to or above 140/90 mm Hg.
• The administration of any investigational drug within 30 days of screening visit.
• Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.

Contacts and Locations

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  Show 41 Study Locations

Sponsors and Collaborators

EndoCeutics Inc.

Investigators

Principal Investigator:	David F Archer, MD	Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA

More Information

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Publications of Results:

Labrie F, Archer DF, Bouchard C, Girard G, Ayotte N, Gallagher JC, Cusan L, Baron M, Blouin F, Waldbaum AS, Koltun W, Portman DJ, Côté I, Lavoie L, Beauregard A, Labrie C, Martel C, Balser J, Moyneur É; Members of the VVA Prasterone Group. Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas. 2015 May;81(1):46-56. doi: 10.1016/j.maturitas.2015.02.005. Epub 2015 Feb 16.

Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Côté I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.

Ke Y, Gonthier R, Simard JN, Archer D, Lavoie L, Martel C, Vaillancourt M, Labrie F. Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA. Horm Mol Biol Clin Investig. 2015 Dec;24(3):117-29. doi: 10.1515/hmbci-2015-0035.

Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dubé R; other participating members of VVA Prasterone Group. Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women. Menopause. 2015 Dec;22(12):1289-95. doi: 10.1097/GME.0000000000000470.

Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur É; 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.

Responsible Party:	EndoCeutics Inc.
ClinicalTrials.gov Identifier:	NCT01256671 History of Changes
Other Study ID Numbers:	ERC-230
First Posted:	December 8, 2010
Results First Posted:	October 18, 2017
Last Update Posted:	October 18, 2017
Last Verified:	September 2017

Keywords provided by EndoCeutics Inc.:

Vulvar/Vaginal Atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA	Prasterone; Vaginorm; Menopause; Intrarosa

Additional relevant MeSH terms:

Atrophy; Pathological Conditions, Anatomical; Dehydroepiandrosterone	Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs