A Comparative, Open-Label, Controlled, monocentric study to determine the serum and Intraperitoneal fluids concentrations of vaginal applications of danazol (100mg/die) in comparison to administration of danazol oral capsules (600mg/die) in groups of women with suspected or confirmed endometriosis and scheduled for laparoscopy.

A Comparative, Open-Label, Randomized, Parallel Group Study to determine Intraperitoneal fluids, tissue, and serum concentrations of VML-0501 following five days of daily vaginal applications of single dose of VML-0501 (100 mg Danazol), in comparison to five days of Danazol treatment administered as an oral capsules (Danatrol) at a daily dose of 600 mg, in two groups of twelve each consisting of women with suspected or confirmed endometriosis and scheduled for laparoscopy. - VML-0501-001

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000988-32-IT

Enrollment

Registered

2020-11-04

Start date

2017-10-25

Completion date

Unknown

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometriosis MedDRA version: 20.0 Level: LLT Classification code 10014789 Term: Endometriosis, site unspecified System Organ Class: 100000004872

Interventions

Product Name: VML-0501 Product Code: VML-0501 Pharmaceutical Form: Vaginal cream INN or Proposed INN: DANAZOLO CAS Number: 17230-88-5 Current Sponsor code: Danazol Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subject must: • Provide written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of her normal medical care. • Be a female with signs and symptoms of endometriosis • Greater than or equal to 18 years of age and less than 42years. • Scheduled to undergo laparoscopy. • According to the local practice the women should sign a specific clause on avoiding pregnancy based on the use of two effective methods for birth control (condom and spermicidal) following 30 days after the last dose/application. • Be non-pregnant undergoing laparoscopy with signs and symptoms of endometriosis within first 10 days of her cycle. • Have a body mass index (BMI) =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: If any of the following criteria apply, the subject MUST NOT be admitted/continue the study trial. The subject: • Is pregnant (if positive-Urine pregnancy test at screening) or lactating; • Has evidence of drug or alcohol abuse. • Have used hormonal replacement therapy or Danazol therapy within the past 8 weeks before study entry • Has any of the following: Epileptic Seizure, Migraine Headache, Angina, Chronic Heart Failure, Obstruction of a Blood Vessel by a Blood Clot, Liver Problems, Kidney Disease, Pregnancy, Combined High Blood Cholesterol and Triglyceride Level, Porphyria • Undiagnosed abnormal genital bleeding • Androgen dependant tumour • Is Allergic to anabolic androgenic steroid. • Smoker.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of: - Concentrations in serum - Concentrations in peritoneal fluid. ;Secondary Objective: Secondary study outcome: - Concentration in endometrial tissue found outside the uterus (Lesion tissue) ;Primary end point(s): To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of Concentrations in serum, concentrations in peritoneal fluid. ;Timepoint(s) of evaluation of this end point: 5 - 7 days treatment	—

Measure

Time frame

Main Objective: To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of: - Concentrations in serum - Concentrations in peritoneal fluid. ;Secondary Objective: Secondary study outcome: - Concentration in endometrial tissue found outside the uterus (Lesion tissue) ;Primary end point(s): To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of Concentrations in serum, concentrations in peritoneal fluid. ;Timepoint(s) of evaluation of this end point: 5 - 7 days treatment

—

Secondary

Measure	Time frame
Secondary end point(s): To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of concentration in endometrial tissue found outside the uterus (Lesion tissue) ;Timepoint(s) of evaluation of this end point: 5-7 days treatment	—

Countries

Italy

Contacts

Public ContactRicerca Clinica

GB PHARMA SERVICES & CONSULTING SRL-SOCIET¿ UNIPERSONALE

info@gbpharmaservices.it0382530676

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026