Vaginal administration of selective estrogen receptor modulator (Tamoxifen) treatment to improve sexual function for women with breast cancer. A randomized, double-blinded, placebo controlled longitudinal phase 3 study.

Phase 1

• Conditions: Most troublesome vulvovaginal atrophy symptom; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-004536-28-SE
• Lead Sponsor: ppsala University, Department of Women's and Children´s Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

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, < 20 pmol/l.
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.
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 gynecological 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.
8. Have an endometrial thickness of < 4 mm as determined by vaginal ultrasonography, in women with an intact uterus.

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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>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