Authorised Therapeutic confirmatory (Phase III) Vulvovaginal atrophy symptoms

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.

EU CTIS ID: 2024-517315-69-00

What this study is testing

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.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.