A Phase 2 Study to Evaluate the Efficacy and Safety of Pu... | NCT07391241

Studies
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)

NCT07391241

Sponsor

Initiator Pharma

Status

Recruiting

Last Update Posted

Feb 5, 2026Actual

Enrollment

24Estimated

Phase

Phase 2

Conditions

Vulvodynia

Interventions

Pudafensine

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2025Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Jan 21, 2026

First Submission Date that Met QC Criteria

Jan 29, 2026

First Posted Date

Feb 5, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2026

Last Update Posted Date

Feb 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study (IP2015CS05) is a randomised, double-blind, placebo-controlled, 4-way cross-over trial studying the efficacy and safety of single dose administration of pudafensine in vulvodynia (provoked vestibulodynia) patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose_1	Experimental	Pudafensine	Drug: Pudafensine
Dose_2	Experimental	Pudafensine	Drug: Pudafensine
Dose_3	Experimental	Pudafensine	Drug: Pudafensine
Placebo	Placebo Comparator	Placebo	Drug: Pudafensine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pudafensine	Drug	Pudafensine	Dose_1 Dose_2 Dose_3 Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of this study is to evaluate the effect of pudafensine on pain in the vaginal vestibule (vestibular pain threshold) using the Vestibular Pain Threshold Test		Through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant with vulvodynia (provoked vestibulodynia).

Exclusion Criteria:

Women with vulvar pain caused by a specific disorder:
1. Infectious (e.g. recurrent candidiasis, herpes).
2. Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders).
3. Neoplastic (e.g. Paget disease, squamous cell carcinoma).
4. Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma).
5. Trauma (e.g. female genital cutting, obstetrical).
6. Iatrogenic (e.g. postoperative, chemotherapy, radiation).
7. Hormonal deficiencies (e.g. genitourinary syndrome of menopause (vulvovaginal atrophy), lactational amenorrhea).
History or current diagnosis of significant pelvic floor dysfunction.
Co-morbid pelvic pain conditions including pain due to pelvic fractures, pelvic girdle pain or post-partum pelvic pain (to avoid confounding pain outcomes).
History or current diagnosis of pelvic inflammatory disease.
History or current diagnosis of endometriosis.
History or current diagnosis of interstitial cystitis.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Abimbola Babajide, Dr, MBCHB	Contact	+44 01253444451		abimbolababajide@macplc.com

Name	Affiliation	Role
Abimbola Babajide, Dr	MAC, UK	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
MAC	Recruiting	Blackpool			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D056650	Vulvodynia

Ancestor Terms

ID	Term
D014845	Vulvar Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided