SafetyPhase 1NCT07017114
Pentoxifylline PKB171 Gel in Healthy Females Volunteers
A Phase 1 study testing Gel PKB171 in people with Safety and Pharmacokinetics, run by Prokrea BCN, S.L..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Safety, Pharmacokinetics, Maximum Tolerated Dose
- What is being tested?
- Gel PKB171
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2016to 21 Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects had to fulfil all the following criteria to be eligible for study entry:
- 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)*
- 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).
- Medical records and physical examination showing no organic or psychiatric disorders.
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- 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.
- 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.
- DIAGNOSIS AND MAIN CRITERIA FOR INCLUSION:
- Subjects had to fulfil all the following criteria to be eligible for study entry:
- 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)*
- 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).
- 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.
- 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.
- 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.
Who cannot join
- Subjects who met any of the following conditions were not selected for this trial:
- 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.
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- 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.
- Smoking more than 5 cigarettes a day.
- Consuming more than 20 g of alcohol a day.
- Subjects with positive serology for hepatitis B, C or HIV.
- Women with a positive test for syphilis (RPR: rapid plasma reagin).
- Pregnant or breast-feeding women.
- Women who did not commit to using reliable birth control during the study
- 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:
- Did not perform any strenuous physical exercise in the 48 hours prior to the start of each session.
- Did not take any type of drug from the screening visit to the end of the study.
- Did not have intercourse relations with penetration in the 24 hours prior to the start of each study visit.
About this study
Official title: Phase I, 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
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.
Read the detailed description
Phase I, randomised, double-blind, placebo-controlled, dose-escalation study to determine the MTD of PKB171 after single-dose intravaginal administration, followed by a double-blind extension study with multiple-dose vaginal administration (two consecutive days) of PKB171at the MTD in healthy volunteers.
Part A. Dose-Escalation:
A single dose of PKB171 vaginal gel (5 g) was intravaginally administered to healthy volunteers. Three strengths of PKB171 gel were tested: 2% (100 mg pentoxifyline), 3% (150 mg pentoxifyline) and 4% (200 mg pentoxifyline).
Three cohorts of 8 healthy female volunteers participated. Intrapatient dose escalation was not permitted. For each dose level, subjects were randomly allocated to receive either the study drug or the placebo (3:1) between day 7 and 21 of their menstrual cycle. In the first cohort (cohort A), a first volunteer received the study drug; after 24 hours of safety assessment, the rest of the volunteers of that cohort received the study drug (5 volunteers) or placebo (2 volunteers).
Safety and tolerability of each strength level and dose-escalation decisions were made based on the occurrence of drug-related adverse events (AEs). The maximum tolerated dose (MTD) in terms of local tolerability was defined as the highest dose at which no more than 1 of 6 patients experienced a moderate or severe drug-related adverse events following PKB171 gel administration. Dose escalation proceeded until the highest strength of PKB171 vaginal gel (4%) or matching placebo.
To obtain a full PK profile of PKB171 at each dose, blood samples (10 ml) were collected at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 24 hours post-administration (10 blood draws in total) to analyse the pharmacokinetic parameters (Cmax, Tmax, AUC0-t, T1/2, Vd, Clp) of PKB171 and its metabolite 5-OH-pentoxifylline.
Part B. Multiple-dose extension substudy:
After completing the dose-escalation phase, an extension substudy was planned in order to assess the tolerability and PK of PKB171 after multiple-dose administration (two consecutive days) using the MTD in healthy female volunteers.
A subgroup of 6 patients that have participated in the first part of the study were invited to participate in the randomised, parallel-group, placebo-controlled extension study. Patients were randomly allocated to receive either the study drug or the placebo (2:1) between day 7 and 21 of their menstrual cycle. The MTD of PKB171 gel or matching placebo (5 g) were administered intravaginally in two consecutive days.
- Conditions
- Safety, Pharmacokinetics, Maximum Tolerated Dose
- Being tested
- Gel PKB171, Gel PKB171 placebo
- Keywords
- Pharmacokinetics, Maximum tolerated dose (MTD), Local tolerability, pentoxifyline PKB171 Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel PKB171Drug
Also called pentoxifyline gel
Subjects received a single dose of pentoxifylline PKB171 gel or placebo, in a one-dose form with an applicator device that allowed for vaginal administration following the randomisation list:
- First dose level: 2% (100 mg)
- Second dose level: 3% (150 mg)
- Third dose level: 4% (200 mg) The treatment was provided by a member of the investigator's staff and self-administered by volunteers under clinical supervision.
The dose-escalation process enabled to determine MTD or the highest dose that was safe to administer in later studies was determined. The results of this study helped to define the recommended doses to be used in the multiple-dose extension.
Gel PKB171 placeboDrug
Also called placebo gel
PKB vaginal gel at the MTD or placebo once every 24 hours for two consecutive days
| Study group | Role | What they receive |
|---|---|---|
| PKB vaginal gel, at 100 mg pentoxifyline (2% gel). | Experimental | Regarding the dosing schedule, on day 1 of the study (Visit 1) a single dose of investigational drug (of each concentration) or placebo, were administered by intravaginal via using an applicator device (syringe). Receives: Drug: Gel PKB171; Drug: Gel PKB171 placebo |
| PKB vaginal gel, at 150 mg pentoxifyline (3% gel). | Experimental | Regarding the dosing schedule, on day 1 of the study (Visit 1) a single dose of investigational drug (of each concentration) or placebo, were administered by intravaginal via using an applicator device (syringe). Receives: Drug: Gel PKB171; Drug: Gel PKB171 placebo |
| PKB vaginal gel, at 200 mg pentoxifyline (4% gel). | Experimental | Regarding the dosing schedule, on day 1 of the study (Visit 1) a single dose of investigational drug (of each concentration) or placebo, were administered by intravaginal via using an applicator device (syringe). Receives: Drug: Gel PKB171; Drug: Gel PKB171 placebo |
| Placebo for PKB171 | Experimental | Placebo for PKB171 in Part A: dose-escalation and Part B: multiple-dose extension substudy Receives: Drug: Gel PKB171; Drug: Gel PKB171 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of PKB171
To determine the maximum tolerated dose (MTD) of PKB171 according to the dose at which a related adverse event occurs in one or more subjects.
Measured: 3 weeks
Secondary outcomes (11)
Adverse events
Evaluate the adverse events (AEs) reported spontaneusly by the subjects, as well as those what are evident to the investigator, including adverse reactions.
Measured: 3 weeks
Local reactions of PKB171
Evaluate local reactions observed by the gynaecoligist and/or reported by the volunteer after the treatment
Measured: 3 weeks
Visual Analogue Scale
Evaluate the assessment of local reactions reported by VAS (Visual Analogue Scale). Is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best)
Measured: 3 weeks
Pregnancy
In case of pregnancy during the phase I study data collection, including information on pregnancy, fetal development and birth outcomes will be collected.
Measured: 3 weeks
Peak Plasma Concentration (Cmax)
Complete PK profile at each concentration, blood samples (10mL) was drawn at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 12 h post-treatment (10 samples in total), in order to analyze the PK parameters of PKB171 and its metabolite 5-hydroxypentoxyphylline.
Measured: 3 weeks
Tmax
Complete PK profile at each concentration, blood samples (10mL) was drawn at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 12 h post-treatment (10 samples in total), in order to analyze the PK parameters of PKB171 and its metabolite 5-hydroxypentoxyphylline.
Measured: 3 weeks
Area Under the Curve (AUC0-t)
Complete PK profile at each concentration, blood samples (10mL) was drawn at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 12 h post-treatment (10 samples in total), in order to analyze the PK parameters of PKB171 and its metabolite 5-hydroxypentoxyphylline.
Measured: 3 weeks
Volume of Distribution (Vd)
Complete PK profile at each concentration, blood samples (10mL) was drawn at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 12 h post-treatment (10 samples in total), in order to analyze the PK parameters of PKB171 and its metabolite 5-hydroxypentoxyphylline.
Measured: 3 weeks
Half live (T1/2)
Complete PK profile at each concentration, blood samples (10mL) was drawn at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 12 h post-treatment (10 samples in total), in order to analyze the PK parameters of PKB171 and its metabolite 5-hydroxypentoxyphylline.
Measured: 3 weeks
Blood test for pregnancy
A quantitative human chorionic gonadotropin (HCG or hCG) blood test measures the specific level of HCG in the blood. Results are given in milli-international units per milliliter (mIU/mL). In non-pregnant women is less than 5mIU/mL.
In case of pregnancy during the phase I study data collection, including information on pregnancy, fetal development and birth outcomes will be collected.
Measured: 3 weeks
Plasma Clearance (CLp)
Complete PK profile at each concentration, blood samples (10mL) was drawn at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 12 h post-treatment (10 samples in total), in order to analyze the PK parameters of PKB171 and its metabolite 5-hydroxypentoxyphylline.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start27 Jan 2016
- Primary completion26 Apr 2016
- Study completion21 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose-Escalation: A single dose of PKB171 vaginal gel (5 g) was intravaginally administered to healthy volunteers. Three strengths of PKB171 gel were tested: 2% (100 mg), 3% (150 mg) and 4% (200 mg). Three cohorts of 8 healthy female volunteers participated. For each dose level, subjects were randomly allocated to receive either the study drug or the placebo (3:1) between day 7 and 21 of their menstrual cycle. Safety and tolerability of each strength level and dose-escalation decisions. Full PK profile of PKB171 at each dose, blood samples (10 ml) were collected at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 24 hours post-adm were made based on the occurrence of drug-related adverse events (AEs). Multiple-dose extension substudy: The extension substudy was planned in order to assess the tolerability and PK of PKB171 after multiple-dose administration (two consecutive days) using the MTD in healthy female volunteers.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prokrea BCN, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Responsible party
- Sponsor
- Investigators
- José M Palacios, MD, Study chair, ProkreaBCN, S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017114
- Sponsor's protocol ID
- PKB171-01
- Other IDs
- 2015-004611-21, 2015
- Status last verified
- Jun 2025
- First submitted
- 28 Jan 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, 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
- ClinicalTrials.gov ID
- NCT07017114
- Acronym / sponsor ID
- PKB171-01
- Conditions
- Safety, Pharmacokinetics, Maximum Tolerated Dose
- Keywords
- Pharmacokinetics, Maximum tolerated dose (MTD), Local tolerability, pentoxifyline PKB171 Gel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Prokrea BCN, S.L.Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 26 Apr 2016 (actual)
- Study completion
- 21 Sep 2016 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase I, randomised, double-blind, placebo-controlled, dose-escalation study to determine the MTD of PKB171 after single-dose intravaginal administration, followed by a double-blind extension study with multiple-dose vaginal administration (two consecutive days) of PKB171at the MTD in healthy volunteers.
Part A. Dose-Escalation:
A single dose of PKB171 vaginal gel (5 g) was intravaginally administered to healthy volunteers. Three strengths of PKB171 gel were tested: 2% (100 mg pentoxifyline), 3% (150 mg pentoxifyline) and 4% (200 mg pentoxifyline).
Three cohorts of 8 healthy female volunteers participated. Intrapatient dose escalation was not permitted. For each dose level, subjects were randomly allocated to receive either the study drug or the placebo (3:1) between day 7 and 21 of their menstrual cycle. In the first cohort (cohort A), a first volunteer received the study drug; after 24 hours of safety assessment, the rest of the volunteers of that cohort received the study drug (5 volunteers) or placebo (2 volunteers).
Safety and tolerability of each strength level and dose-escalation decisions were made based on the occurrence of drug-related adverse events (AEs). The maximum tolerated dose (MTD) in terms of local tolerability was defined as the highest dose at which no more than 1 of 6 patients experienced a moderate or severe drug-related adverse events following PKB171 gel administration. Dose escalation proceeded until the highest strength of PKB171 vaginal gel (4%) or matching placebo.
To obtain a full PK profile of PKB171 at each dose, blood samples (10 ml) were collected at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 24 hours post-administration (10 blood draws in total) to analyse the pharmacokinetic parameters (Cmax, Tmax, AUC0-t, T1/2, Vd, Clp) of PKB171 and its metabolite 5-OH-pentoxifylline.
Part B. Multiple-dose extension substudy:
After completing the dose-escalation phase, an extension substudy was planned in order to assess the tolerability and PK of PKB171 after multiple-dose administration (two consecutive days) using the MTD in healthy female volunteers.
A subgroup of 6 patients that have participated in the first part of the study were invited to participate in the randomised, parallel-group, placebo-controlled extension study. Patients were randomly allocated to receive either the study drug or the placebo (2:1) between day 7 and 21 of their menstrual cycle. The MTD of PKB171 gel or matching placebo (5 g) were administered intravaginally in two consecutive days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Dose-Escalation: A single dose of PKB171 vaginal gel (5 g) was intravaginally administered to healthy volunteers. Three strengths of PKB171 gel were tested: 2% (100 mg), 3% (150 mg) and 4% (200 mg). Three cohorts of 8 healthy female volunteers participated. For each dose level, subjects were randomly allocated to receive either the study drug or the placebo (3:1) between day 7 and 21 of their menstrual cycle. Safety and tolerability of each strength level and dose-escalation decisions. Full PK profile of PKB171 at each dose, blood samples (10 ml) were collected at baseline (pre-treatment), 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h and 24 hours post-adm were made based on the occurrence of drug-related adverse events (AEs). Multiple-dose extension substudy: The extension substudy was planned in order to assess the tolerability and PK of PKB171 after multiple-dose administration (two consecutive days) using the MTD in healthy female volunteers.
| Arm | Type | Receives |
|---|---|---|
| PKB vaginal gel, at 100 mg pentoxifyline (2% gel). | Experimental | Drug: Gel PKB171, Drug: Gel PKB171 placeboRegarding the dosing schedule, on day 1 of the study (Visit 1) a single dose of investigational drug (of each concentration) or placebo, were administered by intravaginal via using an applicator device (syringe). |
| PKB vaginal gel, at 150 mg pentoxifyline (3% gel). | Experimental | Drug: Gel PKB171, Drug: Gel PKB171 placeboRegarding the dosing schedule, on day 1 of the study (Visit 1) a single dose of investigational drug (of each concentration) or placebo, were administered by intravaginal via using an applicator device (syringe). |
| PKB vaginal gel, at 200 mg pentoxifyline (4% gel). | Experimental | Drug: Gel PKB171, Drug: Gel PKB171 placeboRegarding the dosing schedule, on day 1 of the study (Visit 1) a single dose of investigational drug (of each concentration) or placebo, were administered by intravaginal via using an applicator device (syringe). |
| Placebo for PKB171 | Experimental | Drug: Gel PKB171, Drug: Gel PKB171 placeboPlacebo for PKB171 in Part A: dose-escalation and Part B: multiple-dose extension substudy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- 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)*
- 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).
- Medical records and physical examination showing no organic or psychiatric disorders.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gel PKB171Also: pentoxifyline gelSubjects received a single dose of pentoxifylline PKB171 gel or placebo, in a one-dose form with an applicator device that allowed for vaginal administration following the randomisation list: * First dose level: 2% (100 mg) * Second dose level: 3% (150 mg) * Third dose level: 4% (200 mg) The treatment was provided by a member of the investigator's staff and self-administered by volunteers under clinical supervision. The dose-escalation process enabled to determine MTD or the highest dose that was safe to administer in later studies was determined. The results of this study helped to define the recommended doses to be used in the multiple-dose extension. | Drug | PKB vaginal gel, at 100 mg pentoxifyline (2% gel)., PKB vaginal gel, at 150 mg pentoxifyline (3% gel)., PKB vaginal gel, at 200 mg pentoxifyline (4% gel)., Placebo for PKB171 |
| Gel PKB171 placeboAlso: placebo gelPKB vaginal gel at the MTD or placebo once every 24 hours for two consecutive days | Drug | PKB vaginal gel, at 100 mg pentoxifyline (2% gel)., PKB vaginal gel, at 150 mg pentoxifyline (3% gel)., PKB vaginal gel, at 200 mg pentoxifyline (4% gel)., Placebo for PKB171 |
Primary outcome
Maximum Tolerated Dose (MTD) of PKB171
Time frame: 3 weeks
To determine the maximum tolerated dose (MTD) of PKB171 according to the dose at which a related adverse event occurs in one or more subjects.
11 secondary outcomes
Adverse events
Time frame: 3 weeks
Local reactions of PKB171
Time frame: 3 weeks
Visual Analogue Scale
Time frame: 3 weeks
Pregnancy
Time frame: 3 weeks
Peak Plasma Concentration (Cmax)
Time frame: 3 weeks
Tmax
Time frame: 3 weeks
Area Under the Curve (AUC0-t)
Time frame: 3 weeks
Volume of Distribution (Vd)
Time frame: 3 weeks
Half live (T1/2)
Time frame: 3 weeks
Blood test for pregnancy
Time frame: 3 weeks
Plasma Clearance (CLp)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José M Palacios, MD study chair
ProkreaBCN, S.L.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gel PKB171 in people with Safety and Pharmacokinetics, run by Prokrea BCN, S.L..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of PKB171 (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.