Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing 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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03352076

Enrollment

Registered

2017-11-24

Start date

2017-12-28

Completion date

2020-05-26

Last updated

2020-06-12

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

Conditions

Endometriosis

Keywords

Danazol

Brief summary

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 capsule (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.

Interventions

DRUGVaginal Danazol

Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol

DRUGOral Danatrol

Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 42 Years

Healthy volunteers

Yes

Inclusion criteria

* 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 who has or is suspected to have 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 for confirmed or suspected endometriosis within first 10 days of her cycle. * Have a body mass index (BMI) \< 32 kg/m2

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	Description
Danazol concentration	6 months	Concentration in serum and peritoneal fluid

Secondary

Measure	Time frame	Description
Danazol concentration	6 months	Concentration in endometrial tissue found outside the uterus

Other

Measure	Time frame	Description
Danazol concentration	6 months	Concentration in endometrium tissue

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026