Early intervention and recovery of sexual function in men and women after treatment of rectal cancer–a randomized placebo-controlled study with tadalafil

Phase 1

Conditions: sexual/ erectile function in women and men after treatment for rectal cancer
MedDRA version: 20.0Level: HLGTClassification code 10013356Term: Sexual function and fertility disordersSystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Not possible to specify

Registration Number: EUCTR2017-004916-21-SE

Lead Sponsor: Karolinska Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 160

Inclusion Criteria

1. Men and women with rectal cancer stage I-III after clinical and radiologic staging, intention to
transabdominal resection of rectal cancer.
2. Patient reported sexual activity before diagnosis or symptoms of rectal cancer according to FSFI-6 and IIEF-5.
3. Age over 18 years
4. Fluent in oral and written Swedish language
5. Females must not be lactating or pregnant at baseline documented by pregnancy test.
6. Given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Evidence of systemic disease (metastases)
2. History or evidence of urogenital malignancy
3. History of pelvic radiation
4. Concomitant use of anti-androgens or androgens
5. Contraindications to the use of tadalafil (PDE5-inhibitor)
6. Impaired performance status (Eastern Cooperative Oncology Group (ECOG) performance score above 1.
7. Serious co-existing mental disorder or medical condition e.g. anaemia, liver or renal failure, cardiovascular disease or diabetes.
8. Ongoing drug or alcohol abuse dependence.
9. Has a condition or has received medical treatment that, in the judgement of the investigator, precluded successful participation in the study.