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Early intervention and recovery of sexual function in men and women after treatment of rectal cancer–a randomized placebo-controlled study with tadalafil
EU CTIS ID: 2023-504592-24-00
What this study is testing
To evaluate the effect of prophylactic intake of 5 mg tadalafil on sexual/erectile function in women and men within a standardized rehabilitation program after treatment for rectal cancer.
- Therapeutic exploratory (Phase II)
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
- Men and women with rectal cancer stage I-III after clinical and radiologic staging, intention to transabdominal resection of rectal cancer.
- Patient reported sexual activity before diagnosis or symptoms of rectal cancer according to FSFI-6 and IIEF-5.
- Age over 18 years
- Fluent in oral and written Swedish language
- Females must not be lactating or pregnant at baseline documented by pregnancy test.
- Given written informed consent
You likely can't join if
- Evidence of systemic disease (metastases)
- History or evidence of urogenital malignancy
- History of pelvic radiation
- Concomitant use of anti-androgens or androgens
- Contraindications to the use of tadalafil (PDE5-inhibitor)
- Impaired performance status (Eastern Cooperative Oncology Group (ECOG) performance score above 1.
See the full eligibility criteria
- Men and women with rectal cancer stage I-III after clinical and radiologic staging, intention to transabdominal resection of rectal cancer.
- Patient reported sexual activity before diagnosis or symptoms of rectal cancer according to FSFI-6 and IIEF-5.
- Age over 18 years
- Fluent in oral and written Swedish language
- Females must not be lactating or pregnant at baseline documented by pregnancy test.
- Given written informed consent
- Evidence of systemic disease (metastases)
- History or evidence of urogenital malignancy
- History of pelvic radiation
- Concomitant use of anti-androgens or androgens
- Contraindications to the use of tadalafil (PDE5-inhibitor)
- Impaired performance status (Eastern Cooperative Oncology Group (ECOG) performance score above 1.
- Serious co-existing mental disorder or medical condition e.g. anaemia, liver or renal failure, cardiovascular disease or diabetes.
- Ongoing drug or alcohol abuse dependence.
- Has a condition or has received medical treatment that, in the judgement of the investigator, precluded successful participation in the study.
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 all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
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.