Pentoxifylline PKB171 Gel in Healthy Females Volunteers (NCT07017114) | Clinical Trial Compass
CompletedPhase 1
Pentoxifylline PKB171 Gel in Healthy Females Volunteers
30 participantsStarted 2016-01-27
Plain-language summary
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Clinical Trial to evaluate the Safety and Tolerability of Pentoxifylline PKB171 Gel in Single-Dose Intravaginal Administration, followed by an Extension Study with Multiple-Dose Administration in Healthy Volunteers. The primary ojective was to determine the maximum tolerated dose (MTD) in terms of local tolerability of PKB171 after single-dose intravaginal administration in healthy female volunteers; the secondary objectives evaluated the safety and tolerability of PKB171 after single-dose intravaginal administration and the pharmacokinetic (PK) profile of PKB171 after single-dose intravaginal administration.
The extension substudy evaluated the safety and tolerability of PKB171 after multiple-dose intravaginal administration at the MTD in healthy volunteers.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Understand and agree to the trial procedures and sign an informed consent form.
✓. Female volunteers aged between 18 and 45 years.
✓. Regular menstrual cycle (regardless of menstrual cycle length)\*
✓. Medical records and physical examination showing no organic or psychiatric disorders.
✓. Gynaecological examination with visual inspection by the gynaecologist to rule out possible signs/symptoms of inflammation or vaginal infection and/or other gynaecological diseases, such as vulvovaginitis, infectious vulvovaginitis, candidal vulvovaginitis or fungal infection, trichomoniasis, bacterial vaginosis, irritative vulvovaginitis (due to the use of vaginal douching, deodorants, etc.), condylomata or genital warts, bartholinitis, cervicitis, etc. Symptoms: increased vaginal discharge and characteristics' change (colour, smell, texture and appearance) that varied according to the agent causing the infection, redness of the vulvar and vaginal mucosae, warts on the labia and/or anus, painful lump (with abscess), etc.
✓. ECG, vital signs and blood and urine tests performed prior to the trial had to be within normal limits. Minor or one-off variations from the normal limits were allowed at the principal investigator's discretion, insofar as they do not pose a risk to subjects and do not interfere in the evaluation of the drug.
. Body mass index (BMI=weight/height2) should be between 18.5 and 24.99 kg/m2
✓. Women who have not participated in a clinical trial involving drugs in the three months prior to this study.
Exclusion criteria
✕. Subjects who were not able to understand the nature of the trial and the procedures that they were asked to follow.
✕. History or clinical evidence of gastrointestinal, liver, renal or other types of disorders that led to a change in how the drug was absorbed, distributed, metabolised or excreted, or which suggested drug-induced gastrointestinal upset.
✕. History or clinical evidence of psychiatric disorders, alcoholism, abuse of medication or other drugs, or habitual consumption of psychoactive drugs.
✕. Any organic disease or major surgery in the 3 months prior to the start of the study.
✕. Subjects who had intolerance or serious adverse reactions to the study drugs or any of their ingredients.
✕. Regular use of medication in the month prior to the study sessions (including birth control or hormone therapy of any kind), except for vitamins or dietary supplements that, in the opinion of the principal investigator or designated supporting staff, involved no risk to subjects and did not interfere with the study objectives. In this case, subjects had to stop taking them from one week before the experimental sessions and until they had been completed. Treatment with single or limited symptomatic medication in the week prior to the study sessions was not cause for exclusion if it was calculated that it had been completely eliminated by the day of the experimental session.