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EndometriosisPhase 3NCT01697111

Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

A Phase 3 study testing EE20/DRSP(BAY86-5300) and Dienogest in people with Endometriosis, run by Bayer at 32 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Endometriosis
What is being tested?
EE20/DRSP(BAY86-5300) and Dienogest
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
312 participants
Where
32 sitesJapan
Study dates
Oct 2012to Dec 2014
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

Who may be able to join

  • Patients diagnosed as having endometriosis by laparotomy or laparoscopy, or by identification of chocolate cyst of endometriosis, or patients with the clinical diagnosis of endometriosis, who fulfill the condition of pelvic tenderness or induration of Cul-de-sac or uterine immobility
  • Patient with pelvic pain judged by the highest Visual Analogue Scale (VAS) value of 40 mm or higher which is determined during 2 menstrual cycles before randomization (baseline observation phase)
  • Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
  • Patients who do not wish to become pregnant during the course of the study

Who cannot join

  • Patients who have organic diseases of which surgical treatment is prioritized by investigator
  • Patients in whom any hormonal therapies, including combined oral contraceptives (COCs) and progestins, have failed for treatment of symptomatic endometriosis (moderate, severe pain)
  • Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
  • Patients for whom dienogest is contraindicated (according to Japanese labeling of Dinagest Tab 1mg)

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Japan32 sites

  • Study site

    Anjo, Aichi-ken, 446-8510

  • Study site

    Bunkyo, Tokyo, 112-0014

  • Study site

    Chuo-ku, Tokyo, 104-0061

  • Study site

    Fuchū, Tokyo, 183-0056

  • Study site

    Fukui-shi, Fukui, 910-0845

  • Study site

    Fukui-shi, Fukui, 910-8526

  • Study site

    Gifu, Gifu, 500-8717

  • Study site

    Hachiōji, Tokyo, 192-0046

  • Study site

    Ichinomiya, Aichi-ken, 491-8551

  • Study site

    Itami, Hyōgo, 664-8540

  • Study site

    Kamakura, Kanagawa, 247-8533

  • Study site

    Kanazawa, Ishikawa-ken, 920-8530

  • Study site

    Kawanishi, Hyōgo, 666-0125

  • Study site

    Kawasaki, Kanagawa, 212-0016

  • Study site

    Kitamoto, Saitama, 364-8501

  • Study site

    Kobe, Hyōgo, 654-0047

  • Study site

    Machida, Tokyo, 194-0022

  • Study site

    Matsudo, Chiba, 270-2267

  • Study site

    Minato, Tokyo, 105-0001

  • Study site

    Minato, Tokyo, 107-0051

  • Study site

    Nagoya, Aichi-ken, 451-8511

  • Study site

    Nagoya, Aichi-ken, 460-0011

  • Study site

    Nagoya, Aichi-ken, 464-0066

  • Study site

    Nishitōkyō, Tokyo, 188-0011

  • Study site

    Osaka, Osaka, 530-0001

  • Study site

    Osaka, Osaka, 530-0013

  • Study site

    Osaka, Osaka, 542-0086

  • Study site

    tabashi City, Tokyo, 175-0092

  • Study site

    Takasaki, Gunma, 370-0883

  • Study site

    Toyonaka, Osaka, 560-0022

  • Study site

    Yokohama, Kanagawa, 230-0001

  • Study site

    Yokohama, Kanagawa, 231-0023

Other trials in Japan

About this study

Official title: A Multi-center, Randomized, Double-blinded, Placebo-controlled, and Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of an Extended Flexible Regimen of BAY 86-5300 [0.02 mg Ethinylestradiol (β-CDC) and 3 mg Drospirenone] in the Patients With Endometriosis

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase.

The primary objective of this study is to confirm the superiority of BAY86-5300 when administered with an extended flexible regimen for the treatment of endometriosis-associated pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.

The secondary objective is to investigate the long-term safety of BAY86-5300 in patients treated with an extended flexible regimen for one year, and the bleeding pattern of BAY86-5300 when administered with an extended flexible regimen compared to dienogest.

Conditions
Endometriosis
Being tested
EE20/DRSP(BAY86-5300), Placebo, Dienogest
Keywords
YAZ, Flexible regimen, Drospirenone, Ethinylestradiol Betadex, Endometriosis, Dienogest, Japanese Patients
Medical subject headings
Endometriosis

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

  • PlaceboDrug

    One tablet (no active ingredient) / day and one tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day, for the first 24 weeks and the later 28 weeks, respectively

  • DienogestDrug

    Dienogest 1mg twice a day (bid)

Study groups in NCT01697111
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: EE20/DRSP(BAY86-5300)
Arm 2ExperimentalNot described
Receives: Drug: Placebo
Arm 3Active comparatorNot described
Receives: Drug: Dienogest

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)

    The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)

    Measured: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)

Secondary outcomes (7)

  1. Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)

    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.

    Measured: Weeks 17-24 of treatment period

  2. Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)

    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.

    Measured: Weeks 17-24 of treatment period

  3. Dyspareunia

    In case having sexual intercourse, dyspareunia pain is the worst pain on a 0-10 scale rated by the participant in the last 24 hours.

    Measured: Weeks 17-24 of treatment period

  4. Average of pain

    The average of pain is the mean value of the Visual Analogue Scale (VAS) value during the time frame calculated for each patient based on daily record of Patient Diary.

    Measured: Weeks 17-24 of treatment period

  5. Size of chocolate cyst

    In case chocolate cyst is detected, size of chocolate cyst is a mean length (mm) of the longest axis and the short axis (crossing) of the largest chocolate cyst determined by transvaginal ultrasonography.

    Measured: 24 weeks after taking the initial study medication

  6. Endometrial thickness

    Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.

    Measured: 24 weeks after taking the initial study medication

  7. Number of days with spotting/bleeding

    Number of days with spotting/bleeding is determined based on daily record of Patient Diary.

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionMar 2014
  4. Study completionDec 2014

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01697111
Sponsor's protocol ID
15457
Status last verified
Jan 2016
First submitted
28 Sep 2012
Last updated
18 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • Harada T, Kosaka S, Elliesen J, Yasuda M, Ito M, Momoeda M. Ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen for the management of endometriosis-associated pelvic pain: a randomized controlled trial. Fertil Steril. 2017 Nov;108(5):798-805. doi: 10.1016/j.fertnstert.2017.07.1165. Epub 2017 Sep 11.

    PubMed 28911925

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EE20/DRSP(BAY86-5300) and Dienogest in people with Endometriosis, run by Bayer at 32 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?

The sponsor lists 4 inclusion and 4 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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?

Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24) (time frame: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)). 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 NCT01697111, 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 18 Feb 2016.

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