Pentoxifylline PKB171 Gel in Healthy Females Volunteers

Inclusion criteria Subjects had to fulfil all the following criteria to be eligible for study entry: 1. Understand and agree to the trial procedures and sign an informed consent form. 2. Female volunteers aged between 18 and 45 years. 3. Regular menstrual cycle (regardless of menstrual cycle length)\* \*Subjects were asked for the duration of their menstrual cycle and the date of last menstruation in order to identify the stage of their menstrual cycle between days 7 and 21, and depending on their menstrual cycle they were distributed over the three consecutive study periods (and also to have them identified for the extension substudy). 4. Medical records and physical examination showing no organic or psychiatric disorders. 5. 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. In addition, during clinical examination, the gynaecologist asked volunteers about the presence of symptoms (pruritus or itching of the external genitalia and/or vagina, sensation of burning or stinging in the genitalia, urinary tract problems such as frequent urination, burning urination, heavy flow, etc.) to confirm the diagnosis. 6. 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. 7. Body mass index (BMI=weight/height2) should be between 18.5 and 24.99 kg/m2 8. Women who have not participated in a clinical trial involving drugs in the three months prior to this study. DIAGNOSIS AND MAIN CRITERIA FOR INCLUSION: Inclusion criteria Subjects had to fulfil all the following criteria to be eligible for study entry: 1. Understand and agree to the trial procedures and sign an informed consent form. 2. Female volunteers aged between 18 and 45 years. 3. Regular menstrual cycle (regardless of menstrual cycle length)\* \*Subjects were asked for the duration of their menstrual cycle and the date of last menstruation in order to identify the stage of their menstrual cycle between days 7 and 21, and depending on their menstrual cycle they were distributed over the three consecutive study periods (and also to have them identified for the extension substudy). 4. Medical records and physical examination showing no organic or psychiatric disorders. 5. 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. In addition, during clinical examination, the gynaecologist asked volunteers about the presence of symptoms (pruritus or itching of the external genitalia and/or vagina, sensation of burning or stinging in the genitalia, urinary tract problems such as frequent urination, burning urination, heavy flow, etc.) to confirm the diagnosis. 6. 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. 7. Body mass index (BMI=weight/height2) should be between 18.5 and 24.99 kg/m2 8. Women who have not participated in a clinical trial involving drugs in the three months prior to this study. Exclusion criteria Subjects who met any of the following conditions were not selected for this trial: 1. Subjects who were not able to understand the nature of the trial and the procedures that they were asked to follow. 2. 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. 3. History or clinical evidence of psychiatric disorders, alcoholism, abuse of medication or other drugs, or habitual consumption of psychoactive drugs. 4. Any organic disease or major surgery in the 3 months prior to the start of the study. 5. Subjects who had intolerance or serious adverse reactions to the study drugs or any of their ingredients. 6. 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. 7. Smoking more than 5 cigarettes a day. 8. Consuming more than 20 g of alcohol a day. 9. Subjects with positive serology for hepatitis B, C or HIV. 10. Women with a positive test for syphilis (RPR: rapid plasma reagin). 11. Pregnant or breast-feeding women. 12. Women who did not commit to using reliable birth control during the study 13. Women who had any contraindication specified in the summary of product characteristics of oral pentoxifylline. To be eligible, subjects had to agree to the following restrictions regarding diet, sex, drug use and exercise during the study: 1. Did not perform any strenuous physical exercise in the 48 hours prior to the start of each session. 2. Did not take any type of drug from the screening visit to the end of the study. 3. Did not have intercourse relations with penetration in the 24 hours prior to the start of each study visit.