Trial | NCT03352076  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
Study Started
Dec 28
2017
Primary Completion
Oct 24
2019
Study Completion
May 26
2020
Last Update
Jun 12
2020

Drug Vaginal Danazol

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

Drug Oral Danatrol

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

Oral Danatrol Active Comparator

200 mg orally TDS (600 mg daily) for 5-7 days

Vaginal Danazol Experimental

100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose

Criteria 

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.
No Results Posted