DysmenorrheaPhase 3NCT02617537
To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea
A Phase 3 study testing EE20/DRSP(YAZ,BAY86-5300) in people with Dysmenorrhea, run by Bayer.
Trial summary
The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- EE20/DRSP(YAZ,BAY86-5300)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Oct 2017
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from dysmenorrhea for at least the previous 3 months prior to Visit 1 with a minimum visual analogue scale (VAS) score of 30 mm with regard to pain during the menstrual period of the screening period
- Good general health (except for findings related to dysmenorrhea) as proven by medical history
- Patients aged 18 years or older at the time of obtaining informed consent; smokers must not be older than 35 years at the time point of informed consent
- Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains (HPV 16, HPV18).
- Women of childbearing potential must agree that adequate contraception will be used when they are sexually active. This applies from signing of the informed consent form until 2 weeks after the last study drug administration.
Who cannot join
- Pregnancy (confirmed or suspected) or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
- Patients who wish to become pregnant during the course of the study
- Body Mass Index (BMI) > 32 kg/m2
- Hypersensitivity to any ingredient of the study drug
- Laboratory values outside inclusion range before randomization
- Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
About this study
Official title: A Multinational, Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study to Investigate the Efficacy and Safety of the Oral Hormonal Contraceptive BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) Over 16 Weeks for the Treatment of Women With Dysmenorrhea
The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study
- Conditions
- Dysmenorrhea
- Being tested
- EE20/DRSP(YAZ,BAY86-5300), Placebo
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE20/DRSP(YAZ,BAY86-5300)Drug
0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle
PlaceboDrug
Matching placebo tablets for 28 days per 28-day intake cycle
| Study group | Role | What they receive |
|---|---|---|
| BAY86-5300 | Experimental | Patients suffering from dysmenorrhea, treated with Yaz Receives: Drug: EE20/DRSP(YAZ,BAY86-5300) |
| Placebo | Placebo comparator | Patients suffering from dysmenorrhea,treated with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6
The patient marks the individual pain impression on a visual analogue scale in the range 0 (no pain) to 100mm (worst pain ever experienced)
Measured: Baseline to week 17
Secondary outcomes (10)
Number of participants with adverse events as measure of safety and tolerability
Measured: Up to 16 weeks
Number of days with dysmenorrhea
The occurrence of dysmenorrhea will be recorded in the patient diary
Measured: Up to 16 weeks
Change in dysmenorrhea score
It is the sum of two four-stage sub-scales which assess the extent to which dysmenorrhea interferes with daily life \& the extent to which pain medication is used.
Measured: Baseline to week 16
Changes from baseline to each menstrual period of total number of taken supportive analgesic medication
Standard Analgesic tablets are provided to participants
Measured: Baseline to week 16
Changes from baseline to each menstrual period of days without supportive analgesic medication.
Measured: Baseline to week 16
Clinical Global Impression(CGI)
The CGI is the measure of global improvement index from the opinion of the investigator and subject to document changes in the health status during treatment
Measured: At week 16
Self administered SF-36 questionnaire
The 36-items Short Form Health Survey (SF-36) (version 2.0) is a set of generic, coherent,and easily administered quality-of-life measures.
Measured: At baseline and week 17
Changes from baseline to each menstrual period of severity of lumbago
The patient classifies the severity on a mild, moderate, severe scale
Measured: Up to 16 weeks
Changes from baseline to each menstrual period of severity of headache
The patient classifies the severity on a mild, moderate, severe scale
Measured: Up to 16 weeks
Changes from baseline to each menstrual period of severity of nausea/vomiting
The patient classifies the severity on a mild, moderate, severe scale
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
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.
- More trials run by BayerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617537
- Sponsor's protocol ID
- 16419
- Other IDs
- 2015-003924-29, 2015
- Status last verified
- Feb 2016
- First submitted
- 23 Nov 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study to Investigate the Efficacy and Safety of the Oral Hormonal Contraceptive BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) Over 16 Weeks for the Treatment of Women With Dysmenorrhea
- ClinicalTrials.gov ID
- NCT02617537
- Acronym / sponsor ID
- 16419
- Conditions
- Dysmenorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 1 Dec 2015 (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 objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY86-5300 | Experimental | Drug: EE20/DRSP(YAZ,BAY86-5300)Patients suffering from dysmenorrhea, treated with Yaz |
| Placebo | Placebo comparator | Drug: PlaceboPatients suffering from dysmenorrhea,treated with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from dysmenorrhea for at least the previous 3 months prior to Visit 1 with a minimum visual analogue scale (VAS) score of 30 mm with regard to pain during the menstrual period of the screening period
- Good general health (except for findings related to dysmenorrhea) as proven by medical history
- Patients aged 18 years or older at the time of obtaining informed consent; smokers must not be older than 35 years at the time point of informed consent
- Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains (HPV 16, HPV18).
- Women of childbearing potential must agree that adequate contraception will be used when they are sexually active. This applies from signing of the informed consent form until 2 weeks after the last study drug administration.
Key exclusion criteria (8 listed)
- Pregnancy (confirmed or suspected) or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
- Patients who wish to become pregnant during the course of the study
- Body Mass Index (BMI) > 32 kg/m2
- Hypersensitivity to any ingredient of the study drug
- Laboratory values outside inclusion range before randomization
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 |
|---|---|---|
| EE20/DRSP(YAZ,BAY86-5300)0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle | Drug | BAY86-5300 |
| PlaceboMatching placebo tablets for 28 days per 28-day intake cycle | Drug | Placebo |
Primary outcome
Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6
Time frame: Baseline to week 17
The patient marks the individual pain impression on a visual analogue scale in the range 0 (no pain) to 100mm (worst pain ever experienced)
10 secondary outcomes
Number of participants with adverse events as measure of safety and tolerability
Time frame: Up to 16 weeks
Number of days with dysmenorrhea
Time frame: Up to 16 weeks
Change in dysmenorrhea score
Time frame: Baseline to week 16
Changes from baseline to each menstrual period of total number of taken supportive analgesic medication
Time frame: Baseline to week 16
Changes from baseline to each menstrual period of days without supportive analgesic medication.
Time frame: Baseline to week 16
Clinical Global Impression(CGI)
Time frame: At week 16
Self administered SF-36 questionnaire
Time frame: At baseline and week 17
Changes from baseline to each menstrual period of severity of lumbago
Time frame: Up to 16 weeks
Changes from baseline to each menstrual period of severity of headache
Time frame: Up to 16 weeks
Changes from baseline to each menstrual period of severity of nausea/vomiting
Time frame: Up to 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EE20/DRSP(YAZ,BAY86-5300) in people with Dysmenorrhea, run by Bayer.
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 8 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: withdrawn, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6 (time frame: Baseline to week 17). 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 17 Feb 2016.