Most troublesome vulvovaginal atrophy symptom
Conditions
Interventions
Trade Name: Tamoxifen Sandoz
Product Name: Tamoxifen Sandoz
Pharmaceutical Form: Tablet
INN or Proposed INN: Tamoxifen
CAS Number: 54965-24-1
Other descriptive name: TAMOXIFEN CITRATE
Concentration u
Sponsors
Uppsala University, Department of Women's and Children´s Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sexually active postmenopausal women with breast cancer and ongoing adjuvant antiestrogen treatment with aromatase inhibitors who are willing to participate in the study and give their written consent. 2. Postmenopausal women with at least 12 months of spontaneous amenorrhea, or women who have had surgical bilateral oophorectomy at least 6 weeks ago, or level of follicle stimulating hormone (FSH) > 40 mIU/mL. 3. Have a vaginal pH > 5.0 at screening. 5. Have estradiol levels below the detection level, =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Postmenopausal women with breast cancer and ongoing adjuvant antiestrogen treatment with oral tamoxifen. In addition, women meeting any of the following criteria will not be permitted to enter the study: 1. Have a history of cardiovascular disease or thromboembolic events. 2. Have a history of or ongoing hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the principal investigator. 3. Have a history of endometrial hyperplasia, endometrial polyps, endometrial cancer, or ovarian cancer. 4. Have a history of undiagnosed vaginal bleeding. 5. Have an ongoing urogenital infection in spite of treatment at the randomization visit. 6. Have used estrogen alone or estrogen/progestin for any of the following time periods: a. Vaginal hormonal products (rings, creams, gels, vaginal suppositories) within 12 weeks prior to the screening visit;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of most troublesome vulvovaginal atrophy symptom. At randomization, the severity of the most troublesome VVA symptom will be noted and improvement of the most troublesome VVA, yes/no, a dichotomized variable will be the primary endpoint.;Secondary Objective: Overall sexual function objective parameters for improved vuvlvovaginal atrophy such as vaginal pH, percentage superficial and parabasal cells;Primary end point(s): Change from baseline to week 12 in severity of most troublesome VVA symptom measured with Endocrine Subscale-FACT-B. At randomization, the severity of the most troublesome VVA symptom will be noted and improvement of the most troublesome VVA, yes/no, a dichotomized variable will be the primary endpoint.;Timepoint(s) of evaluation of this end point: 4 and 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline to week 12 in all subscales of the modified version of the Endocrine Subscale-FACT-B • Change from baseline to week 4 and 12 in total score FSFI. • Change from baseline to week 4 and 12 in total score on the FSDS-R • Change from baseline to Week 4 and 12 in Quality of Life collected using the EORTC QLQ-C30. • Change from baseline to Week 4 and 12 scores in HADS. • Change from baseline to Week 4 and 12 in vaginal pH, percentage superficial cells (increase is positive), percentage parabasal cells (decrease is positive), and vaginal maturation index (increase is positive). • Change from baseline to Week 4 and 12 in vaginal pH, percentage superficial cells (increase is positive), percentage parabasal cells (decrease is positive), and vaginal maturation index (increase is positive). Secondary safety endpoints • Change from baseline to week 12 in endometrial thickness as determined by vaginal ultrasonography. • Hyperplasia on endometrial biopsy • Change from baseline to week 12 in estradiol, Follicle stimulating hormone, tamoxifen, and endoxifen serum concentrations. • Change from baseline over time of clinical safety data: adverse events, vital signs, physical examination findings, gynecological examination findings, breast examination findings, and laboratory tests. ;Timepoint(s) of evaluation of this end point: 4 and 12 weeks of treament | — |
Countries
Sweden
Contacts
Public ContactWomen's and Children's Health
Uppsala university
Outcome results
None listed