Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 36 for:    DANAZOL
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03352076
Recruitment Status : Active, not recruiting
First Posted : November 24, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Viramal Limited

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Vaginal Danazol Drug: Oral Danatrol Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 28, 2017
Actual Primary Completion Date : October 24, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Danazol

Arm Intervention/treatment
Active Comparator: Oral Danatrol
200 mg orally TDS (600 mg daily) for 5-7 days
Drug: Oral Danatrol
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol

Experimental: Vaginal Danazol
100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose
Drug: Vaginal Danazol
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol




Primary Outcome Measures :
  1. Danazol concentration [ Time Frame: 6 months ]
    Concentration in serum and peritoneal fluid


Secondary Outcome Measures :
  1. Danazol concentration [ Time Frame: 6 months ]
    Concentration in endometrial tissue found outside the uterus


Other Outcome Measures:
  1. Danazol concentration [ Time Frame: 6 months ]
    Concentration in endometrium tissue

  2. Danazol concentration [ Time Frame: 6 months ]
    Concentration in myometrium tissue



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352076


Locations
Layout table for location information
Italy
Ospedale L. Sacco - Milan-Obgyn Unit
Milan, Italy, 20157
Sponsors and Collaborators
Viramal Limited
Investigators
Layout table for investigator information
Study Director: Simona Fiore, Dr Viramal Limited

Layout table for additonal information
Responsible Party: Viramal Limited
ClinicalTrials.gov Identifier: NCT03352076     History of Changes
Other Study ID Numbers: VML-0501-001
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viramal Limited:
Danazol
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometriosis
Genital Diseases, Female
Danazol
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs