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Completed

NCT Number: NCT03352076

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 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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale L. Sacco - Milan-Obgyn Unit

Milan, 20157, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal Danazol

Drug

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

Oral Danatrol

Drug

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

Primary outcomes

  1. Danazol concentration

    Time frame: 6 months

    Concentration in serum and peritoneal fluid

Secondary outcomes

  1. Danazol concentration

    Time frame: 6 months

    Concentration in endometrial tissue found outside the uterus

Other outcomes

  1. Danazol concentration

    Time frame: 6 months

    Concentration in endometrium tissue

  2. Danazol concentration

    Time frame: 6 months

    Concentration in myometrium tissue

Sponsors and collaborators

Lead sponsor

Viramal Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 24, 2017
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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