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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Uppsala University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Decision date (initial)

2024-08-30

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517315-69-00

EudraCT number

2021-004536-28

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective is to evaluate the efficacy of vaginal tamoxifen in reducing the most troublesome vulvovaginal atrophy symptom in women with breast cancer evaluated by use of Endocrine Subscale- FACT-B.

Conditions and MedDRA coding

Vulvovaginal atrophy symptoms

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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. 4. Have ≤ 5% superficial cells in vaginal smear cytology 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 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. 8. Have an endometrial thickness of < 4 mm as determined by vaginal ultrasonography, in women with an intact uterus.

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 1

1. Change from baseline to week 12 in all subscales of the modified version of the Endocrine Subscale-FACT-B. Change from baseline to week 12 in total score on the Female Sexual Function Index (FSFI). Change from baseline to week 12 in total score on the Female Sexual Distress Scale-revised (FSDS-R). Change from baseline to Week 12 in Quality of Life. Information will be collected using the EORTC QLQ-C30

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Uppsala University

Sponsor organisation

Uppsala University

Address

Box 256

City

Uppsala

Postcode

751 05

Country

Sweden

Scientific contact point

Organisation

Uppsala University

Contact name

Inger Sundström Poromaa

Public contact point

Organisation

Uppsala University

Contact name

Inger Sundström Poromaa

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications