A Phase 2 interventional study of Vaginal Danazol and Oral Danatrol in Endometriosis, sponsored by Viramal Limited. Completed at 1 site in Italy. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-12.
Sponsored by Viramal Limited · Phase 2, Interventional, and Treatment
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.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's enrollment of 30 is below the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Viramal Limited is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
If any of the following criteria apply, the subject MUST NOT be admitted/continue the study trial.
The subject:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
200 mg orally TDS (600 mg daily) for 5-7 days
Drug: Oral Danatrol
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
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
Danazol concentration
Concentration in serum and peritoneal fluid
Time frame: 6 months
Danazol concentration
Concentration in endometrial tissue found outside the uterus
Time frame: 6 months
Danazol concentration
Concentration in endometrium tissue
Time frame: 6 months
Danazol concentration
Concentration in myometrium tissue
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Oct 2019, 21 months.
Of 44 phase 2 interventional studies under Endometriosis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 37. This study's 21 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Danazol
Viramal Limited