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:
• •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.