Vulvovaginal atrophy
Conditions
Interventions
Trade Name: Vagifem
Product Name: Estradiol
Product Code: 41707
Pharmaceutical Form: Vaginal tablet
Trade Name: Intrarosa
Product Name: Prasterone
Product Code: EMEA/H/C/004138 - N/0010
Pharmaceutica
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women (non-hysterectomized or hysterectomized) must satisfy either: a) No menses for at least one year for non-hysterectomized women OR b) Follicle stimulating hormone (FSH) levels >40 IU/L 2. Women who have self-identified at screening and baseline as experiencing moderate to severe dyspareunia, using VASQ questionnaire 3. Between 40 and 80 years of age 4. Body mass index (BMI) 19-35 5. Women having a vaginal pH above 5 at screening and baseline 6. Women who currently have intercourse or other sexual activity, at least once a month, with a partner 7. Normal mammogram within 12 months 8. A normal PAP smear (which includes inflammatory changes) within the last 12 months (of baseline) for both non-hysterectomized. 9. Willing to participate in the study and understand and sign a Swedish informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Undiagnosed abnormal vaginal bleeding 2. Previous diagnosis of cancer, except skin cancer (non-melanoma) 3. Lichen Sclerosis and other pathological conditions in vulva and/or vagina 4. Active or history of thromboembolic disease 5. Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication 6. Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy in the 8 weeks prior to baseline assessments (screening visit) 7. Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products in the 4 weeks prior to baseline assessments (screening visit) 8. Use of testosterone or other anabolic steroid within 6 months prior to screening visit 9. Natural oral estrogenic products in the 4 weeks prior to baseline assessments 10. Confirmed clinically significant depression (not controlled by standard therapy) or confirmed history of severe psychiatric disturbance 11. The administration of any investigational drug within 30 days of screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary To compare the effect of intravaginal DHEA and estradiol on dyspareunia, a symptom of VVA in postmenopausal women Primary endpoint will be evaluated as change in dyspareunia (VASQ section 1) from baseline to Week 12 ;Secondary Objective: Secondary To evaluate the effect of local DHEA and estradiol on - total symptom score of VVA (vaginal dryness, irritation/itching, maturation index, pH) - clinical signs of VVA - sexual function - sex hormone levels - vaginal histomorphology - sex steroid hormone receptors - short-term safety ;Primary end point(s): The primary efficacy variable in the study is the difference at week 12, between the two treatment arms, in the proportion of patients obtaining a VASQ (section 1) score improvement (from baseline) of =1 reflecting an improvement of dyspareunia;Timepoint(s) of evaluation of this end point: At week 12 of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables (total symptom score of VVA): - Change from baseline to week 4 and week 12 in vaginal dryness (none, mild, moderate or severe) as patient evaluation through completion of VASQ (section 2) - Change from baseline to week 4 and week 12 in vulvovaginal irritation/itching (none, mild, moderate or severe) as patient evaluation through completion of VASQ (section 3) - Mean change from baseline to week 4 and week 12 in vaginal pH Secondary efficacy variables (clinical signs of VVA): - Change from baseline to week 4 and week 12 in pallor, friability, thinning/flattening of folds, petechiae and dry mucosa (none, mild, moderate or severe ratings) as evaluated by gynecologist Secondary efficacy variables (sexual function): - Mean change from baseline to week 4 and week 12 in the different domains (desire, arousal, orgasm, pleasure, concern, responsiveness and self-image) of PFSF (Profile of Female Sexual Function) will be evaluated by patient self-completion Secondary exploratory variables (sex steroid hormones/metabolites/proteins): - Mean change from baseline to week 4 and week 12 for estrogens, androgens, metabolites and SHBG Secondary exploratory variables (vaginal histomorphology and sex steroid hormone receptor levels): - Vaginal histomorphology (thickness and nerve density in the epithelium, muscularis and lamina propria) and receptors (estrogen a/ß, androgen and progesterone) will be evaluated in 30 women in each treatment arm at baseline, Week 4 and Week 12 ;Timepoint(s) of evaluation of this end point: At week 4 and 12 of treatment | — |
Countries
Sweden
Contacts
Public ContactClinical research unit
Karolinska University Hospital
Outcome results
None listed