EndometriosisPhase 2NCT03352076
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 Phase 2 study testing Vaginal Danazol and Oral Danatrol in people with Endometriosis, run by Viramal Limited at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Vaginal Danazol and Oral Danatrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 28 Dec 2017to 26 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Undiagnosed abnormal genital bleeding
- Androgen dependant tumour
- Is Allergic to anabolic androgenic steroid.
- Smoker.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Endometriosis
- Being tested
- Vaginal Danazol, Oral Danatrol
- Keywords
- Danazol
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal DanazolDrug
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
Oral DanatrolDrug
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
| Study group | Role | What they receive |
|---|---|---|
| Oral Danatrol | Active comparator | 200 mg orally TDS (600 mg daily) for 5-7 days Receives: Drug: Oral Danatrol |
| Vaginal Danazol | Experimental | 100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose Receives: Drug: Vaginal Danazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Danazol concentration
Concentration in serum and peritoneal fluid
Measured: 6 months
Secondary outcomes (1)
Danazol concentration
Concentration in endometrial tissue found outside the uterus
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start28 Dec 2017
- Primary completion24 Oct 2019
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viramal Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simona Fiore, Dr, Study director, Viramal Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352076
- Sponsor's protocol ID
- VML-0501-001
- Status last verified
- Jun 2020
- First submitted
- 17 Nov 2017
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03352076
- Acronym / sponsor ID
- VML-0501-001
- Conditions
- Endometriosis
- Keywords
- Danazol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Viramal LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Danatrol | Active comparator | Drug: Oral Danatrol200 mg orally TDS (600 mg daily) for 5-7 days |
| Vaginal Danazol | Experimental | Drug: Vaginal Danazol100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- If any of the following criteria apply, the subject MUST NOT be admitted/continue the study trial.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal DanazolProof of mechanism study to establish intraperitoneal and serum concentrations of Danazol | Drug | Vaginal Danazol |
| Oral DanatrolProof of mechanism study to establish intraperitoneal and serum concentrations of Danazol | Drug | Oral Danatrol |
Primary outcome
Danazol concentration
Time frame: 6 months
Concentration in serum and peritoneal fluid
1 secondary outcome
Danazol concentration
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simona Fiore, Dr study director
Viramal Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vaginal Danazol and Oral Danatrol in people with Endometriosis, run by Viramal Limited at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Danazol concentration (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.