Study on Vaginal Tamoxifen for Improving Sexual Function in Women with Breast Cancer Experiencing Vulvovaginal Atrophy Symptoms

3 1 1

What is this study about?

This clinical trial is focused on studying the effects of a treatment for women with breast cancer who experience symptoms of vulvovaginal atrophy. Vulvovaginal atrophy is a condition that can cause discomfort in the vaginal area, often affecting sexual function. The treatment being tested is a medication called tamoxifen citrate, which is administered vaginally. Tamoxifen is a type of medication known as a selective estrogen receptor modulator, which means it can block or activate estrogen receptors in different tissues.

The purpose of the study is to evaluate how effective vaginal tamoxifen is in reducing the most bothersome symptoms of vulvovaginal atrophy in women with breast cancer. Participants in the study will be randomly assigned to receive either the tamoxifen treatment or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will last for a period of 12 weeks, during which participants will be monitored for changes in their symptoms and overall quality of life.

Throughout the study, participants will be asked to complete questionnaires that assess their symptoms and quality of life. These questionnaires include the Endocrine Subscale-FACT-B, which is specifically designed for breast cancer research, and other tools like the Female Sexual Function Index and the Female Sexual Distress Scale-revised. The information gathered will help researchers understand the impact of tamoxifen on sexual function and quality of life in women with breast cancer experiencing vulvovaginal atrophy.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. Consent will be obtained to ensure understanding and agreement to participate.

2 screening and baseline assessment

A screening process will be conducted to confirm eligibility. This includes checking for postmenopausal status, breast cancer diagnosis, and ongoing antiestrogen treatment.

Baseline assessments will be performed, including physical and gynecological examinations, blood pressure measurement, and laboratory tests. A vaginal pH test and smear cytology will also be conducted.

3 randomization and treatment initiation

Participants will be randomly assigned to receive either the study medication, tamoxifen citrate, or a placebo. The medication is administered vaginally.

The dosage and frequency of administration will be specified by the study protocol, and participants will be instructed on how to use the medication.

4 treatment period

The treatment period will last for 12 weeks. During this time, participants will continue to use the assigned medication as directed.

Participants will be asked to complete questionnaires to assess symptoms and quality of life, including the Endocrine Subscale-FACT-B and the Female Sexual Function Index (FSFI).

5 follow-up assessments

At the end of the 12-week treatment period, follow-up assessments will be conducted. These will include the same evaluations as the baseline assessments to measure any changes.

Participants will complete additional questionnaires to evaluate changes in symptoms and quality of life.

6 study completion

Upon completion of the study, participants will be informed of the study’s outcomes and any relevant findings.

Participants will be provided with information on any further steps or recommendations based on the study results.

Who Can Join the Study?

Must be a sexually active postmenopausal woman with breast cancer.
Must be receiving ongoing adjuvant antiestrogen treatment with aromatase inhibitors.
Must be willing to participate in the study and provide written consent.
Must be postmenopausal, which means having at least 12 months without a menstrual period, or have had both ovaries surgically removed at least 6 weeks ago, or have a hormone level called follicle stimulating hormone (FSH) greater than 40 mIU/mL.
Must have a vaginal pH greater than 5.0 during the initial screening.
Must have 5% or fewer superficial cells in a vaginal smear test during screening.
Must have estradiol levels, a type of estrogen, below the detection level, which is less than 20 pmol/l.
Must have one moderate to severe symptom of vulvovaginal atrophy that is identified as the most bothersome on a specific scale called the FACT-B scale.
Must be considered in otherwise good health by the principal investigator, which includes:

Normal or not significant findings during a physical examination.
A mean sitting systolic blood pressure of 150 mm Hg or lower and diastolic blood pressure of 90 mm Hg or lower during screening.
Normal or not significant findings during a gynecological examination.
A normal mammogram performed within 36 months before starting the study medication.
Laboratory test results within normal limits or with non-significant deviations.

Must have an endometrial thickness of less than 4 mm as determined by a vaginal ultrasound, if the uterus is intact.

Who Cannot Join the Study?

Patients who are not experiencing symptoms of vulvovaginal atrophy. This condition involves thinning, drying, and inflammation of the vaginal walls.
Patients who are not women. The study is only for female participants.
Patients who are not within the specified age range. The study is for certain age groups only.
Patients who are part of a vulnerable population. This means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
Karolinska University Hospital	Solna	Sweden
Ursxhjf Ueowsnrwvu Hxuwjgqo	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	01.03.2022

Trial locations

Investigated drugs:

Tamoxifen Citrate

Tamoxifen is a medication used in this clinical trial. It is a selective estrogen receptor modulator, which means it can block or activate estrogen receptors in different tissues. In this study, tamoxifen is administered vaginally to women with breast cancer. The goal is to see if it can help improve sexual function by reducing symptoms of vulvovaginal atrophy, which is a common issue for women undergoing breast cancer treatment.

Investigated diseases:

Atrophic vulvovaginitis

Vulvovaginal Atrophy – Vulvovaginal atrophy is a condition often associated with decreased estrogen levels, commonly occurring during menopause. It involves thinning, drying, and inflammation of the vaginal walls, leading to symptoms such as vaginal dryness, itching, and discomfort during intercourse. The condition can also cause urinary symptoms like urgency and increased frequency. Over time, these symptoms may become more pronounced, affecting daily activities and quality of life. The progression of vulvovaginal atrophy varies among individuals, with some experiencing mild symptoms and others facing more severe discomfort.

Trial ID:

2024-517315-69-00

Protocol code:

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider