DysmenorrheaPhase 3NCT01892904
Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
A Phase 3 study testing EE20/DRSP(BAY86-5300) in people with Dysmenorrhea, run by Bayer at 8 sites in Japan.
Trial summary
The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative study (24-week treatment period). The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- EE20/DRSP(BAY86-5300)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 8 sitesJapan
- Study dates
- Jul 2013to Aug 2015
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: - Dysmenorrhea patients with a total dysmenorrhea score (sum of the two sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of the last two menstruations before randomization (baseline observation phase)
- Patients with dysmenorrheic pain during the 2 baseline cycles before randomization. Dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with possible radiation towards back or thighs recorded in the Patient Diary in correspondence with a withdrawal and/or menstrual bleeding episode. Pain could start up to 2 days before the onset of the bleeding episode the bleeding and terminates on the last day of bleeding of before
- Patients having the regular cyclic menstrual period (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
- Willingness to use a barrier method (i.e., non-hormonal method) for contraception during the study. Acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device.
Exclusion Criteria: - Patients who have organic diseases of which surgical treatment is prioritized by the investigator
- Patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in size of the longest diameters
- Patients with ovarian chocolate cysts having solid part in the cyst
- Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Hachiōji, Tokyo, 192-0046
Study site
Matsudo, Chiba, 270-2267
Study site
Minato, Tokyo, 108-0071
Study site
Osaka, Osaka, 530-0013
Study site
Osaka, Osaka, 542-0086
Study site
Setagaya-ku, Tokyo, 157-0066
Study site
Suginami-ku, Tokyo, 167-0051
Study site
Toshima-ku, Tokyo, 171-0021
About this study
Official title: A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of a Flexible Extended Regimen of BAY 86-5300 (0.02 mg Ethinylestradiol [β-CDC] and 3 mg Drospirenone) Compared to the 28-day (24 + 4-day) Regimen of BAY 86-5300 in the Treatment of Dysmenorrhea for 24 Weeks
The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative study (24-week treatment period).
The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation period.
In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients treated for one year will be investigated.
- Conditions
- Dysmenorrhea
- Being tested
- EE20/DRSP(BAY86-5300)
- Keywords
- YAZ, Flexible regimen, Drospirenone, Ethinylestradiol Betadex, Dysmenorrhea, Japanese patients
- 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(BAY86-5300)Drug
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
| Study group | Role | What they receive |
|---|---|---|
| EE20/DRSP(BAY86-5300)-flexibel extended regimen | Experimental | One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with flexible extended regimen (24-day to 120-day active tablet intake followed by 4-day tablet free interval) Receives: Drug: EE20/DRSP(BAY86-5300) |
| EE20/DRSP(BAY86-5300)-28 days cyclic regimen | Active comparator | One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with 28-day cyclic regimen (24-day active tablet intake followed by 4-day placebo tablet intake) Receives: Drug: EE20/DRSP(BAY86-5300) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with dysmenorrheic pain over 140 days of evaluation period
Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.
Measured: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Secondary outcomes (7)
Change in Dysmenorrhea score from baseline to period of withdrawal bleeding
Dysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visit
Measured: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Change of severity of pain Description
The severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit.
Measured: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period
Number of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary.
Measured: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period
Number of days with rescue medicine is determined based on daily record of Patient Diary.
Measured: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period
Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary
Measured: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Endometrial thickness
Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
Measured: 24 weeks after taking the initial study medication
Number of days with bleeding and spotting over treatment phase
Number of days with spotting/bleeding is determined based on daily record of Patient Diary.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 216 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
- NCT01892904
- Sponsor's protocol ID
- 16114
- Status last verified
- Sep 2015
- First submitted
- 2 Jul 2013
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Momoeda M, Akiyama S, Yamamoto S, Kondo M, Fukai T. Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study. Int J Womens Health. 2020 Mar 10;12:175-185. doi: 10.2147/IJWH.S242864. eCollection 2020.
PubMed 32210639
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of a Flexible Extended Regimen of BAY 86-5300 (0.02 mg Ethinylestradiol [β-CDC] and 3 mg Drospirenone) Compared to the 28-day (24 + 4-day) Regimen of BAY 86-5300 in the Treatment of Dysmenorrhea for 24 Weeks
- ClinicalTrials.gov ID
- NCT01892904
- Acronym / sponsor ID
- 16114
- Conditions
- Dysmenorrhea
- Keywords
- YAZ, Flexible regimen, Drospirenone, Ethinylestradiol Betadex, Dysmenorrhea, Japanese patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Jul 2013 (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 is a multi-center, randomized, open-label, active-controlled, parallel-group comparative study (24-week treatment period).
The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation period.
In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients treated for one year will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EE20/DRSP(BAY86-5300)-flexibel extended regimen | Experimental | Drug: EE20/DRSP(BAY86-5300)One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with flexible extended regimen (24-day to 120-day active tablet intake followed by 4-day tablet free interval) |
| EE20/DRSP(BAY86-5300)-28 days cyclic regimen | Active comparator | Drug: EE20/DRSP(BAY86-5300)One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with 28-day cyclic regimen (24-day active tablet intake followed by 4-day placebo tablet intake) |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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(BAY86-5300)One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day | Drug | EE20/DRSP(BAY86-5300)-28 days cyclic regimen, EE20/DRSP(BAY86-5300)-flexibel extended regimen |
Primary outcome
Number of days with dysmenorrheic pain over 140 days of evaluation period
Time frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.
7 secondary outcomes
Change in Dysmenorrhea score from baseline to period of withdrawal bleeding
Time frame: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Change of severity of pain Description
Time frame: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period
Time frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period
Time frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period
Time frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days
Endometrial thickness
Time frame: 24 weeks after taking the initial study medication
Number of days with bleeding and spotting over treatment phase
Time frame: Up to 24 weeks
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 9 Sep 2015.
- Derived from this study: PubMed 32210639Momoeda M, Akiyama S, Yamamoto S, Kondo M, Fukai T. Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study. Int J Womens Health. 2020 Mar 10;12:175-185. doi: 10.2147/IJWH.S242864. eCollection 2020.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EE20/DRSP(BAY86-5300) in people with Dysmenorrhea, run by Bayer at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. 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 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 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?
Number of days with dysmenorrheic pain over 140 days of evaluation period (time frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892904, which also lists 1 linked publication.
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 9 Sep 2015.