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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Vaginal Danazol
* Drug: Oral Danatrol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Danatrol<br>200 mg orally TDS (600 mg daily) for 5-7 days | Drug: Oral Danatrol<br>* Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol<br>|
| Experimental: Vaginal Danazol<br>100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose | Drug: Vaginal Danazol<br>* Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Danazol concentration | Concentration in serum and peritoneal fluid | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Danazol concentration | Concentration in endometrial tissue found outside the uterus | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Danazol