Primary DysmenorrheaPhase 2NCT00963053
VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
A Phase 2 study of Primary Dysmenorrhea, run by Vantia Ltd at 4 sites in 2 countries.
Trial summary
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2009to Nov 2010
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 18 and 35 years old
- Not pregnant
- History of primary dysmenorrhoea
- Regular menstrual cycles
- Signed informed consent
Who cannot join
- Known secondary dysmenorrhoea
- Concomitant use of regular prescription or non prescription medications or herbal remedies
- Any clinically significant medical history or active disease
- Participation in another clinical study in the last 3 months
- Contraindication to chosen rescue medications or allergy to their constituents
- Other protocol defined eligibility criteria may apply
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Premier Research Group
Austin, Texas, 78705
Pivotal Research Centers
Peoria, Arizona, 85381
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: A Randomised, Double Blind, Placebo Controlled, Multicentre, Cross Over Proof of Concept Study to Investigate the Efficacy and Safety of Pre Emptive Administration of Repeated, Oral Doses of VA111913 TS for the Alleviation of Dysmenorrhoea
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Read the detailed description
Dysmenorrhoea is suffered by between 50% and 90% of women of child bearing age. Up to 30% of these women are non-responsive to the currently prescribed therapies. As such it represents an area of unmet medical need. VA111913 inhibits vasopressin-induced contractions of human myometrial strips and human myometrial blood vessels in vitro. By this mechanism, it is anticipated that the pain of dysmenorrhoea, a condition in which myometrial tone and contractions are increased and blood flow to the uterus is decreased compared to normal, may be reduced.
Subjects will be dosed with VA111913 TS and placebo in a cross over design during two consecutive menstrual cycles. They will be dosed for up to a maximum of 6 days, beginning 2 days before the onset of menstruation. Subjects will then assess the menstrual pain, bleeding and amount of analgesia required to treat symptoms during each cycle
- Conditions
- Primary Dysmenorrhea
- Being tested
- VA111913 TS and placebo
- Keywords
- dysmenorrhoea, dysmenorrhea, pain, pre-emptive
- Medical subject headings
- Dysmenorrhea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA111913 TS and placeboDrug
VA111913 TS twice daily for a maximum of 6 days during one menstrual cycle followed by placebo twice daily for up to a maximum of 6 days during a second menstrual cycle in a cross over design
| Study group | Role | What they receive |
|---|---|---|
| VA111913 100mg twice daily | Experimental | Not described Receives: Drug: VA111913 TS and placebo |
| Starch pill | Placebo comparator | Not described Receives: Drug: VA111913 TS and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed using standard scoring system
Measured: 3 months
Secondary outcomes (5)
Safety assessed by laboratory findings, vital signs, ECGs and AEs
Measured: 3 months
Assessment of treatment effectiveness
Measured: 3 months
Requirement for rescue medication
Measured: 3 months
Assessment of menstrual bleeding
Measured: 3 months
PK assessments
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bell, Principal investigator, Bio-Kinetic Europe LimitedStephen E Daniels, Principal investigator, Premier ResearchVernon Yamashiro, Principal investigator, Jean Brown ResearchLouise Taber, Principal investigator, Pivotal Research Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963053
- Sponsor's protocol ID
- 913-002
- Status last verified
- May 2014
- First submitted
- 17 Aug 2009
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled, Multicentre, Cross Over Proof of Concept Study to Investigate the Efficacy and Safety of Pre Emptive Administration of Repeated, Oral Doses of VA111913 TS for the Alleviation of Dysmenorrhoea
- ClinicalTrials.gov ID
- NCT00963053
- Acronym / sponsor ID
- 913-002
- Conditions
- Primary Dysmenorrhea
- Keywords
- dysmenorrhoea, dysmenorrhea, pain, pre-emptive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 Aug 2009 (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.
The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.
Detailed description
Dysmenorrhoea is suffered by between 50% and 90% of women of child bearing age. Up to 30% of these women are non-responsive to the currently prescribed therapies. As such it represents an area of unmet medical need. VA111913 inhibits vasopressin-induced contractions of human myometrial strips and human myometrial blood vessels in vitro. By this mechanism, it is anticipated that the pain of dysmenorrhoea, a condition in which myometrial tone and contractions are increased and blood flow to the uterus is decreased compared to normal, may be reduced.
Subjects will be dosed with VA111913 TS and placebo in a cross over design during two consecutive menstrual cycles. They will be dosed for up to a maximum of 6 days, beginning 2 days before the onset of menstruation. Subjects will then assess the menstrual pain, bleeding and amount of analgesia required to treat symptoms during each cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA111913 100mg twice daily | Experimental | Drug: VA111913 TS and placebo |
| Starch pill | Placebo comparator | Drug: VA111913 TS and placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between 18 and 35 years old
- Not pregnant
- History of primary dysmenorrhoea
- Regular menstrual cycles
- Signed informed consent
Key exclusion criteria (6 listed)
- Known secondary dysmenorrhoea
- Concomitant use of regular prescription or non prescription medications or herbal remedies
- Any clinically significant medical history or active disease
- Participation in another clinical study in the last 3 months
- Contraindication to chosen rescue medications or allergy to their constituents
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 and placeboVA111913 TS twice daily for a maximum of 6 days during one menstrual cycle followed by placebo twice daily for up to a maximum of 6 days during a second menstrual cycle in a cross over design | Drug | Starch pill, VA111913 100mg twice daily |
Primary outcome
Pain assessed using standard scoring system
Time frame: 3 months
5 secondary outcomes
Safety assessed by laboratory findings, vital signs, ECGs and AEs
Time frame: 3 months
Assessment of treatment effectiveness
Time frame: 3 months
Requirement for rescue medication
Time frame: 3 months
Assessment of menstrual bleeding
Time frame: 3 months
PK assessments
Time frame: 3 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 22 May 2014.
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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.
David Bell principal investigator
Bio-Kinetic Europe Limited
Stephen E Daniels principal investigator
Premier Research
Vernon Yamashiro principal investigator
Jean Brown Research
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Primary Dysmenorrhea, run by Vantia Ltd at 4 sites in 2 countries.
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 5 inclusion and 6 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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. Some participants in this study may receive a placebo. 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?
Pain assessed using standard scoring system (time frame: 3 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 22 May 2014.