TAMOXIFEN CITRATE for Breast cancer|Vulvovaginal atrophy

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 3. Have a vaginal pH > 5.0 at screening."}
• {"criterion_text":"- 4. Have ≤ 5% superficial cells in vaginal smear cytology at screening."}
• {"criterion_text":"- 5. Have estradiol levels below the detection level, < 20 pmol/l."}
• {"criterion_text":"- 6. Have one moderate to severe vulvovaginal atrophy symptom on the FACT-B scale that has been identified by the subject as being the most bothersome to her."}
• {"criterion_text":"- 7. Be judged by the principal investigator as being in otherwise good health. The medical evaluation findings must include: a. A normal or clinically non-significant finding at physical examination. b. A mean sitting systolic blood pressure ≤150 mm Hg and diastolic blood pressure ≤90 mm Hg at screening. c. A normal or clinically non-significant finding at gynaecological examination. d. A normal mammography that has been performed within 36 months prior to initial dose of study medication. e. Laboratory values within normal limits or with non-significant deviations from normal values."}
• {"criterion_text":"- 8. Have an endometrial thickness of < 4 mm as determined by vaginal ultrasonography, in women with an intact uterus."}

Exclusion criteria

• {"criterion_text":"- Postmenopausal women with breast cancer and ongoing adjuvant antiestrogen treatment with oral tamoxifen."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 3. Have a history of endometrial hyperplasia, endometrial polyps, endometrial cancer, or ovarian cancer."}
• {"criterion_text":"- 4. Have a history of undiagnosed vaginal bleeding."}
• {"criterion_text":"- 5. Have an ongoing urogenital infection in spite of treatment at the randomization visit."}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint will be captured by a modified version of the Endocrine Subscale-FACT-B, a validated 5-point response scale (not at all/minor/moderate/considerable/severe) developed for breast cancer research","definition_or_measurement_approach":"Captured by a modified version of the Endocrine Subscale-FACT-B, a validated 5-point response scale (not at all/minor/moderate/considerable/severe)."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline to week 12 in all subscales of the modified version of the Endocrine Subscale-FACT-B.","definition_or_measurement_approach":"Change from baseline to week 12 measured using the modified Endocrine Subscale-FACT-B subscales."}
• {"endpoint_text":"- Change from baseline to week 12 in total score on the Female Sexual Function Index (FSFI).","definition_or_measurement_approach":"Change from baseline to week 12 in FSFI total score."}
• {"endpoint_text":"- Change from baseline to week 12 in total score on the Female Sexual Distress Scale-revised (FSDS-R).","definition_or_measurement_approach":"Change from baseline to week 12 in FSDS-R total score."}
• {"endpoint_text":"- Change from baseline to Week 12 in Quality of Life. Information will be collected using the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline to week 12 in QoL measured by EORTC QLQ-C30."}

Sweden

Earliest CTIS Part Ii Submission Date

19-08-2024

Latest Decision Or Authorization Date

30-08-2024

Processing Time Days

11

Number Of Sites

3

Number Of Participants

120

Primary sponsor

Full Name

Uppsala University

Organisation Type

Educational Institution

Country Of Registered Address

Sweden