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DysmenorrheaPhase 2/3NCT00461305

Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

A Phase 2/3 study testing DRSP 3 mg/EE 20 µg (13 cycles) and DRSP 3 mg/EE 30 µg (6 cycles) in people with Dysmenorrhea, run by Bayer at 26 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

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety 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?
DRSP 3 mg/EE 20 µg (13 cycles) and DRSP 3 mg/EE 30 µg (6 cycles)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
26 sitesJapan
Study dates
Feb 2007to Aug 2009
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 aged 20 years or older at obtaining informed consent
  • Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
  • Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment

Who cannot join

  • Patients with ovarian chocolate cysts
  • Patients with fibroid needed to be treated
  • Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
  • Patients with undiagnosed abnormal vaginal bleeding
  • Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases
  • Patients aged 35 years or older who smoke at least 15 cigarettes per day
Show all 11Show fewer
  • Patients with migraine accompanied by prodromata
  • Patients with pulmonary hypertension or valvular heart disease
  • Patients who are regularly taking nutritional products that contain St. John's Wort
  • Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
  • Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Japan26 sites

  • Study site

    Chuo-ku, Tokyo, 104-0061

  • Study site

    Hachiōji, Tokyo, 192-0046

  • Study site

    Kobe, Hyōgo, 650-0021

  • Study site

    Machida, Tokyo, 194-0022

  • Study site

    Maebashi, Gunma, 371-0024

  • Study site

    Musashino, Tokyo, 180-0003

  • Study site

    Nagoya, Aichi-ken, 460-0007

  • Study site

    Nagoya, Aichi-ken, 460-0011

  • Study site

    Nagoya, Aichi-ken, 464-0066

  • Study site

    Nishinomiya, Hyōgo, 663-8204

  • Study site

    Osaka, Osaka, 530-0013

  • Study site

    Osaka, Osaka, 534-0014

  • Study site

    Ōta-ku, Tokyo, 144-0052

  • Study site

    Sendai, Miyagi, 980-0021

  • Study site

    Sendai, Miyagi, 981-0933

  • Study site

    Sendai, Miyagi, 984-0042

  • Study site

    Setagaya-ku, Tokyo, 156-0042

  • Study site

    Setagaya-ku, Tokyo, 157-0066

  • Study site

    Shibuya-ku, Tokyo, 150-0013

  • Study site

    Shinagawa-ku, Tokyo, 140-0013

  • Study site

    Suginami-ku, Tokyo, 167-0051

  • Study site

    Takasaki, Gunma, 370-0883

  • Study site

    Toshima-ku, Tokyo, 171-0021

  • Study site

    Toyonaka, Osaka, 560-0022

  • Study site

    Yamato, Kanagawa, 242-0007

  • Study site

    Yokohama, Kanagawa, 231-0861

Other trials in Japan

About this study

Official title: A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

Read the detailed description

The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.

The trial is sponsored by Bayer Yakuhin, Ltd.

Conditions
Dysmenorrhea
Being tested
DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)
Keywords
Dysmenorrhea, Intracyclic bleeding, Drospirenone (DRSP), Ethinylestradiol
Medical subject headings
Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DRSP 3 mg/EE 20 µg (13 cycles)Drug

    1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)

  • DRSP 3 mg/EE 30 µg (6 cycles)Drug

    1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)

Study groups in NCT00461305
Study groupRoleWhat they receive
DRSP 3 mg/EE 20 µg (13 cycles)Experimental1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
Receives: Drug: DRSP 3 mg/EE 20 µg (13 cycles)
DRSP 3 mg/EE 30 µg (6 cycles)Experimental1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Receives: Drug: DRSP 3 mg/EE 30 µg (6 cycles)

What is being measured

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

  1. Number of Participants With Intracyclic Bleeding at Cycle 6

    Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

Secondary outcomes (34)

  1. Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6

    Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.

    Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle

  2. Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13

    Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.

    Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle

  3. Distribution of Total Dysmenorrhea Score at Cycle 6

    Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  4. Distribution of Total Dysmenorrhea Score at Cycle 13

    Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  5. Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6

    Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  6. Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13

    Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  7. Distribution of Severity of Lumbago During Menstruation at Cycle 6

    Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  8. Distribution of Severity of Lumbago During Menstruation at Cycle 13

    Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  9. Distribution of Severity of Headache During Menstruation at Cycle 6

    Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  10. Distribution of Severity of Headache During Menstruation at Cycle 13

    Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  11. Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6

    Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  12. Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13

    Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  13. Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6

    Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  14. Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13

    Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  15. Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6

    VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).

    Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle

  16. Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13

    VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).

    Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle

  17. Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6

    VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).

    Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle

  18. Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13

    VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).

    Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle

  19. Number of Any Bleeding Episodes From Cycle 1 to Cycle 6

    Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  20. Number of Any Bleeding Episodes From Cycle 1 to Cycle 13

    Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  21. Number of Any Bleeding Days From Cycle 1 to Cycle 6

    Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  22. Number of Any Bleeding Days From Cycle 1 to Cycle 13

    Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  23. Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6

    Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  24. Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13

    Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  25. Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6

    Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  26. Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13

    Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  27. Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6

    Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  28. Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13

    Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  29. Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6

    Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).

    Measured: Up to Cycle 6 (168 days) with 28 days per cycle

  30. Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13

    Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).

    Measured: Up to Cycle 13 (364 days) with 28 days per cycle

  31. Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6

    CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.

    Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle

  32. Change in Serum CA-125 From Baseline to Cycle 13

    CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.

    Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle

  33. Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6

    CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.

    Measured: From baseline up to Cycle 6 (168 days) with 28 days per cycle

  34. Change in Serum CRP From Baseline to Cycle 13

    CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.

    Measured: From baseline up to Cycle 13 (364 days) with 28 days per cycle

Timeline

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

  1. First posted18 Apr 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionJan 2009
  4. Study completionAug 2009

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00461305
Sponsor's protocol ID
91616
Other IDs
310284
Status last verified
Jan 2013
First submitted
17 Apr 2007
Last updated
24 Jan 2013
Data monitoring committee
No

Publications

  • Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.

    PubMed 37523477

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DRSP 3 mg/EE 20 µg (13 cycles) and DRSP 3 mg/EE 30 µg (6 cycles) in people with Dysmenorrhea, run by Bayer at 26 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 3 inclusion and 11 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 1 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants With Intracyclic Bleeding at Cycle 6 (time frame: Up to Cycle 6 (168 days) with 28 days per cycle). 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 NCT00461305, 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 24 Jan 2013.

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