DysmenorrheaPhase 1NCT00769964
VA111913 TS: First in Human Study
A Phase 1 study of Dysmenorrhea, run by Vantia Ltd at 1 site in United Kingdom.
Trial summary
This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the treatment of dysmenorrhea. This study is designed to investigate determine the safety, tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy non-pregnant female volunteers of child bearing… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2008to Mar 2009
- Phase
- Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females 18 to 45 years of age.
- Subjects must have a negative pregnancy test at screening and admission. Using acceptable form of contraceptive during and after study.
Who cannot join
- Administration of any IMP within 12 weeks before entry to the study or any prescribed medicine within 14days of the study.
- Any clinically important medical disease, condition or abnormal laboratory test results.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Charles River Clinical Services
Edinburgh, EH33 2NE
About this study
Official title: A First in Human Study Consisting of a Two-Part, Double-Blind, Placebo-Controlled, Escalating Single and Multiple Dose Study of VA111913 TS in Adult Non-Pregnant Women Volunteers With a Single Dose, Open, Fed vs. Fasting Crossover Phase
This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the treatment of dysmenorrhea. This study is designed to investigate determine the safety, tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy non-pregnant female volunteers of child bearing age.
Read the detailed description
VA111913 TS is a selective V1a-receptor antagonist. The hypothesised mechanism of action of a V1a receptor antagonist in dysmenorrhea has been described in literature. Contractions of the uterine muscle are required for normal menstruation. Women with dysmenorrhea have increased uterine myometrial tone and contractions and decreased blood flow to the uterus. These abnormalities have been shown to lead to the pain experienced in dysmenorrhea. Thus, if a drug is able to reduce the hyperreactivity of the uterus to physiological levels then the pain experienced in dysmenorrhea may be controlled. In humans, vasopressin, via the V1a receptor, is able to potently induce contractions in both uterine smooth muscle and uterine blood vessels. Thus, a V1a receptor antagonist will potentially inhibit these contractions and in turn reduce the pain experienced in dysmenorrhea.
- Conditions
- Dysmenorrhea
- Being tested
- VA111913 TS / placebo
- Keywords
- Healthy (Dysmenorrhea)
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA111913 TS / placeboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies 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 1
- Primary purpose
- Treatment
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769964
- Sponsor's protocol ID
- 913-001
- Status last verified
- Jun 2009
- First submitted
- 8 Oct 2008
- Last updated
- 25 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Study Consisting of a Two-Part, Double-Blind, Placebo-Controlled, Escalating Single and Multiple Dose Study of VA111913 TS in Adult Non-Pregnant Women Volunteers With a Single Dose, Open, Fed vs. Fasting Crossover Phase
- ClinicalTrials.gov ID
- NCT00769964
- Acronym / sponsor ID
- 913-001
- Conditions
- Dysmenorrhea
- Keywords
- Healthy (Dysmenorrhea)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Oct 2008 (estimated)
- 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.
This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the treatment of dysmenorrhea. This study is designed to investigate determine the safety, tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy non-pregnant female volunteers of child bearing age.
Detailed description
VA111913 TS is a selective V1a-receptor antagonist. The hypothesised mechanism of action of a V1a receptor antagonist in dysmenorrhea has been described in literature. Contractions of the uterine muscle are required for normal menstruation. Women with dysmenorrhea have increased uterine myometrial tone and contractions and decreased blood flow to the uterus. These abnormalities have been shown to lead to the pain experienced in dysmenorrhea. Thus, if a drug is able to reduce the hyperreactivity of the uterus to physiological levels then the pain experienced in dysmenorrhea may be controlled. In humans, vasopressin, via the V1a receptor, is able to potently induce contractions in both uterine smooth muscle and uterine blood vessels. Thus, a V1a receptor antagonist will potentially inhibit these contractions and in turn reduce the pain experienced in dysmenorrhea.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy females 18 to 45 years of age.
- Subjects must have a negative pregnancy test at screening and admission. Using acceptable form of contraceptive during and after study.
Key exclusion criteria (3 listed)
- Administration of any IMP within 12 weeks before entry to the study or any prescribed medicine within 14days of the study.
- Any clinically important medical disease, condition or abnormal laboratory test results.
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| VA111913 TS / placebo | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Jun 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Dysmenorrhea, run by Vantia Ltd at 1 site in United Kingdom.
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 2 inclusion and 3 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 25 Jun 2009. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 25 Jun 2009.