DysmenorrheaPhase 2/3NCT00511797

SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

A Phase 2/3 study testing SH T04740B, SH T00186DF and SH T04740F in people with Dysmenorrhea, run by Bayer at 12 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 drospirenone for dysmenorrhea. 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?: SH T04740B, SH T00186DF and SH T04740F
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 249 participants
Where: 12 sitesJapan
Study dates: Jul 2007to Jan 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 (28+/-3 days) in the latest two menses before the final enrollment
Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment

Who cannot join

Patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in greater detail in the study protocol)
Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear examination.)
Patients with undiagnosed abnormal vaginal bleeding
Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), or a history of those diseases
Patients aged 35 years or older who smoke at least 15 cigarettes per day
Patients with migraine accompanied by prodrome (e.g. scintillating scotoma or star-shaped scintillation)

Show all 10Show fewer

Patients with pulmonary hypertension or valvular heart disease complicated by atrial fibrillation, and patients with a history of subacute bacterial endocarditis
Patients who are regularly taking nutritional products that contain St. John's Wort
Patients who underwent surgical treatment for endometriosis by laparotomy, or laparoscopy within 2 months prior to screening
Patients who need to use analgesics regularly for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Japan12 sites

Study site
Chuo-ku, Tokyo, 104-0061
Study site
Hachiōji, Tokyo, 192-0046
Study site
Kobe, Hyōgo, 650-0021
Study site
Kyoto, Kyoto, 612-0064
Study site
Maebashi, Gunma, 371-0024
Study site
Nishinomiya, Hyōgo, 663-8204
Study site
Osaka, Osaka, 530-0013
Study site
Sendai, Miyagi, 981-0933
Study site
Setagaya-ku, Tokyo, 156-0042
Study site
Setagaya-ku, Tokyo, 157-0066
Study site
Toshima-ku, Tokyo, 171-0021
Study site
Yokohama, Kanagawa, 231-0861

Other trials in Japan

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A [Drospirenone 1 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)], SH T 04740E [Drospirenone 2 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] and SH T00186D [Drospirenone 3 mg/ Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] Administered Orally for 16 Weeks (4 Cycles), and to Confirm the Efficacy of SH T00186D for Dysmenorrhea.

The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.

Conditions: Dysmenorrhea
Being tested: SH T04740B, SH T00186DF, SH T04740F, Placebo
Keywords: Dysmenorrhea, Dysmenorrheal score, 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.

SH T04740BDrug
Drospirenone 1mg/EE 20µg (ß-CDC)
SH T00186DFDrug
Drospirenone 3 mg/EE 20µg (ß-CDC)
SH T04740FDrug
Drospirenone 2 mg/EE 20µg (ß-CDC)
PlaceboDrug
Placebo

Study groups in NCT00511797
Study group	Role	What they receive
DRSP 1 mg/EE 20 μg	Experimental	1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle Receives: Drug: SH T04740B
DRSP 2 mg/EE 20 μg	Experimental	1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle Receives: Drug: SH T04740F
DRSP 3 mg/EE 20 μg	Experimental	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 Receives: Drug: SH T00186DF
Placebo	Placebo comparator	1 tablet per day placebo for 28 days in each 28-day cycle Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Total Dysmenorrheal Score at Final Evaluation
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). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Measured: Baseline and up to 4 Cycles (28 days per cycle)

Secondary outcomes (19)

Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
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). Total possible best is 0, and total possible worst is 6.
Measured: Baseline and up to 4 Cycles (28 days per cycle)
Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
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: Cycle 4 (28 days per cycle)
Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
Severity of low back 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: Cycle 4 (28 days per cycle)
Number of Participants With Severity of Headache During Menstruation at Cycle 4
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: Cycle 4 (28 days per cycle)
Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
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: Cycle 4 (28 days per cycle)
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
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: Cycle 4 (28 days per cycle)
Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4
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 4 (28 days per cycle)
Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4
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: Cycle 4 (28 days per cycle)
Change From Baseline in Endometrial Thickness After 4-cycle Treatment
Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.
Measured: From baseline to Cycle 4 (28 days per cycle)
Number of Bleeding / Spotting Episodes
Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.
Measured: For the first 90 days
Number of Bleeding / Spotting Days
Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.
Measured: For the first 90 days
Participants With Withdrawal Bleeding
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Measured: At Cycle 4 (28 days per cycle)
Participants With Intracyclic Bleeding
Intracyclic bleedings were defined as bleedings while a participant takes active drugs.
Measured: At Cycle 4 (28 days per cycle)
Participants With Non-heavy Intracyclic Bleeding
Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Measured: At Cycle 4 (28 days per cycle)
Participants With Non-heavy Withdrawal Bleeding
Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Measured: At Cycle 4 (28 dyas per cycle)
Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment
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 to Cycle 4 (28 days per cycle)
Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment
CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.
Measured: From baseline to Cycle 4 (28 days per cycle)
Change From Baseline in Serum Estradiol Level After 4-cycle Treatment
Estradiol is a predominant sex hormone that presents in female.
Measured: From baseline to Cycle 4 (28 days per cycle)
Change From Baseline in Serum Progesterone Level at Cycle 4
Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.
Measured: From baseline to Cycle 4 (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.

Jul 2007Jan 2009

First posted6 Aug 2007 (estimated)
Study startJul 2007
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00511797
Sponsor's protocol ID: 91615
Other IDs: 310283
Status last verified: Nov 2016
First submitted: 3 Aug 2007
Last updated: 26 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Momoeda M, et al. Treatment of Functional and Organic Dysmenorrhea - Investigation of the Efficacy and Safety of Drospirenone/Ethinylestradiol Combination Tablet (YAZ). Sanka to Fujinka (Obstetrics and Gynecology), 2010: 77 (8) 977-88 (in Japanese)
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysmenorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A [Drospirenone 1 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)], SH T 04740E [Drospirenone 2 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] and SH T00186D [Drospirenone 3 mg/ Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] Administered Orally for 16 Weeks (4 Cycles), and to Confirm the Efficacy of SH T00186D for Dysmenorrhea.
ClinicalTrials.gov ID: NCT00511797
Acronym / sponsor ID: 91615
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea, Dysmenorrheal score, Drospirenone, DRSP, Ethinylestradiol
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 249 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 6 Aug 2007 (estimated)
Results: Posted 4 Oct 2010

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 this study is to investigate efficacy of drospirenone for dysmenorrhea.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
DRSP 1 mg/EE 20 μg	Experimental	Drug: SH T04740B1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
DRSP 2 mg/EE 20 μg	Experimental	Drug: SH T04740F1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
DRSP 3 mg/EE 20 μg	Experimental	Drug: SH T00186DF1 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
Placebo	Placebo comparator	Drug: Placebo1 tablet per day placebo for 28 days in each 28-day cycle

Who may qualify

Ages: 20 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients aged 20 years or older at obtaining informed consent
Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment
Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment

Key exclusion criteria (10 listed)

Patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in greater detail in the study protocol)
Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear examination.)
Patients with undiagnosed abnormal vaginal bleeding
Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), or a history of those diseases
Patients aged 35 years or older who smoke at least 15 cigarettes per day

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
SH T04740BDrospirenone 1mg/EE 20µg (ß-CDC)	Drug	DRSP 1 mg/EE 20 μg
SH T00186DFDrospirenone 3 mg/EE 20µg (ß-CDC)	Drug	DRSP 3 mg/EE 20 μg
SH T04740FDrospirenone 2 mg/EE 20µg (ß-CDC)	Drug	DRSP 2 mg/EE 20 μg
PlaceboPlacebo	Drug	Placebo

Primary outcome

Change From Baseline in Total Dysmenorrheal Score at Final Evaluation
Time frame: Baseline and up to 4 Cycles (28 days per cycle)
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). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)

19 secondary outcomes

Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
Time frame: Baseline and up to 4 Cycles (28 days per cycle)
Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
Time frame: Cycle 4 (28 days per cycle)
Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
Time frame: Cycle 4 (28 days per cycle)
Number of Participants With Severity of Headache During Menstruation at Cycle 4
Time frame: Cycle 4 (28 days per cycle)
Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
Time frame: Cycle 4 (28 days per cycle)
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
Time frame: Cycle 4 (28 days per cycle)
Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4
Time frame: From baseline up to Cycle 4 (28 days per cycle)
Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4
Time frame: Cycle 4 (28 days per cycle)
Change From Baseline in Endometrial Thickness After 4-cycle Treatment
Time frame: From baseline to Cycle 4 (28 days per cycle)
Number of Bleeding / Spotting Episodes
Time frame: For the first 90 days
Number of Bleeding / Spotting Days
Time frame: For the first 90 days
Participants With Withdrawal Bleeding
Time frame: At Cycle 4 (28 days per cycle)
Participants With Intracyclic Bleeding
Time frame: At Cycle 4 (28 days per cycle)
Participants With Non-heavy Intracyclic Bleeding
Time frame: At Cycle 4 (28 days per cycle)
Participants With Non-heavy Withdrawal Bleeding
Time frame: At Cycle 4 (28 dyas per cycle)
Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment
Time frame: From baseline to Cycle 4 (28 days per cycle)
Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment
Time frame: From baseline to Cycle 4 (28 days per cycle)
Change From Baseline in Serum Estradiol Level After 4-cycle Treatment
Time frame: From baseline to Cycle 4 (28 days per cycle)
Change From Baseline in Serum Progesterone Level at Cycle 4
Time frame: From baseline to Cycle 4 (28 days per cycle)

Results and safety

Results posted to the registry on 4 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DRSP 1 mg/EE 20 μg	62	55
DRSP 2 mg/EE 20 μg	63	55
DRSP 3 mg/EE 20 μg	62	51
Placebo	62	47

Primary outcome: Change From Baseline in Total Dysmenorrheal Score at Final Evaluation

Time frame: Baseline and up to 4 Cycles (28 days per cycle). Mean (Standard Deviation). Unit: scores on a scale

Measure	DRSP 1 mg/EE 20 μg n = 61	DRSP 2 mg/EE 20 μg n = 62	DRSP 3 mg/EE 20 μg n = 61	Placebo n = 58
Value	-2.5 (1.52)	-2.1 (1.51)	-1.9 (1.63)	-1.0 (1.53)

DRSP 3 mg/EE 20 μg vs Placebo: Median Difference (Final Values): -0.92 (95% CI -1.49 to -0.34), p <0.001, t-test, 1 sided
DRSP 2 mg/EE 20 μg vs Placebo: Median Difference (Final Values): -1.10 (95% CI -1.64 to -0.55), p <0.001, t-test, 1 sided
DRSP 1 mg/EE 20 μg vs Placebo: Median Difference (Final Values): -1.44 (95% CI -2.00 to -0.89), p <0.001, t-test, 1 sided

Population analysed: FAS

19 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DRSP 1 mg/EE 20 μg	1 of 62 (1.6%)	56 of 62 (90.3%)	Not reported
DRSP 2 mg/EE 20 μg	2 of 63 (3.2%)	58 of 63 (92.1%)	Not reported
DRSP 3 mg/EE 20 μg	0 of 62 (0%)	60 of 62 (96.8%)	Not reported
Placebo	1 of 62 (1.6%)	53 of 62 (85.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationMomoeda M, et al. Treatment of Functional and Organic Dysmenorrhea - Investigation of the Efficacy and Safety of Drospirenone/Ethinylestradiol Combination Tablet (YAZ). Sanka to Fujinka (Obstetrics and Gynecology), 2010: 77 (8) 977-88 (in Japanese)
Derived from this study: PubMed 37523477Schroll 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.

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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

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SH T04740B, SH T00186DF and SH T04740F in people with Dysmenorrhea, run by Bayer at 12 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 10 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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. 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 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 4 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?

Change From Baseline in Total Dysmenorrheal Score at Final Evaluation (time frame: Baseline and up to 4 Cycles (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 NCT00511797, which also lists 2 linked publications.

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 26 Jan 2017.