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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517315-69-00

Acronym

Enrollment

120

Registered

2024-08-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvovaginal atrophy symptoms

Brief summary

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

Detailed description

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

Interventions

DRUGTAMOXIFEN

DRUGATC-kod V03AX10. Hittas ej av systemet.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

—

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026