Premenstrual Dysphoric Disorder ( PMDD)Phase 3NCT00824187
YAZ Premenstrual Dysphoric Disorder (PMDD) in China
A Phase 3 study testing EE20/DRSP(YAZ, BAY86-5300) in people with Premenstrual Dysphoric Disorder ( PMDD), run by Bayer at 16 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premenstrual Dysphoric Disorder ( PMDD)
- 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
- 187 participants
- Where
- 16 sitesChina
- Study dates
- Jan 2009to Jan 2011
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)
Who cannot join
- Any formal psychotherapeutic counselling within 1 month before the screening visit (Visit 1) or used medication for Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) including, but not limited to hormones, bromocriptine, GnRH agonists, vitamin B6 (>100 mg), calcium supplements (> 1500 mg/day), anxiolytics and antidepressants during the 3 month period prior to Visit 1
- Use of sleeping medication (including melatonin) for more than 3 days per month.
- Pregnancy or less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment
- Obesity (body mass index or BMI > 30 kg/m2)
- Hypersensitivity to any ingredient of the study drug
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Study site
Beijing, 100050
Study site
Beijing, 100191
Study site
Beijing, 100853
Study site
Changsha, Hunan, 410011
Study site
Chengdu, Sichuan, 610041
Study site
Dalian, Liaoning, 116011
Study site
Guangzhou, Guangdong, 510405
Study site
Guangzhou, Guangdong, 510630
Study site
Hangzhou, Zhejiang, 310003
Study site
Jinan, Shandong, 250012
Study site
Kunming, Yunnan, 650032
Study site
Nanjing, Jiangsu, 210029
Study site
Tianjin, 300193
Study site
Wuhan, Hubei, 430060
Study site
Xi’an, Shanxi, 710032
Study site
Xi’an, Shanxi, 710061
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Monophasic Oral Contraceptive YAZ (20 µg Ethinylestradiol, 3 mg Drospirenone) in the Treatment of Chinese Patients With Premenstrual Dysphoric Disorder (PMDD)
The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).
- Conditions
- Premenstrual Dysphoric Disorder ( PMDD)
- Being tested
- EE20/DRSP(YAZ, BAY86-5300), Placebo
- Keywords
- Premenstrual Dysphoric Disorder ( PMDD), Oral contraceptive
- Medical subject headings
- Premenstrual Dysphoric Disorder
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
20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
PlaceboDrug
Inert tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: EE20/DRSP(YAZ, BAY86-5300) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days before menses of the 3rd cycle in the treatment phase to average scores from the last 5 days before menses of the 2 run in cycles
Measured: 3 cycles (1 cycle= 28 days)
Secondary outcomes (6)
The difference in DRSP scale scores for the 3 functional impairment items, comparing the average over the last 5 days of daily scores from the 3rd cycle in the treatment phase to the average of daily scores from the 2 run in cycles
Measured: 3 cycles
Descriptive statistics for total DRSP scale scores (sum of the first 21 items) of the last 5 days for each of the 2 run in cycles, each of the 3 cycles in the treatment phase, and the average of the 3 cycles in the treatment phase
Measured: 3 cylces
Descriptive statistics for change in total DRSP scale scores (sum of the first 21 items) of the last 5 days from baseline to each cycle in the treatment phase and to the average of the 3 cycles in the treatment phase
Measured: 3 cycles
Assessment of CGI scores
Measured: 3 cycles
Adverse events
Measured: Whole study period
Laboratory tests
Measured: Whole study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Dysphoric Disorder ( PMDD)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 187 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
- NCT00824187
- Sponsor's protocol ID
- 91771
- Other IDs
- 311962
- Status last verified
- Apr 2014
- First submitted
- 15 Jan 2009
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Monophasic Oral Contraceptive YAZ (20 µg Ethinylestradiol, 3 mg Drospirenone) in the Treatment of Chinese Patients With Premenstrual Dysphoric Disorder (PMDD)
- ClinicalTrials.gov ID
- NCT00824187
- Acronym / sponsor ID
- 91771
- Conditions
- Premenstrual Dysphoric Disorder ( PMDD)
- Keywords
- Premenstrual Dysphoric Disorder ( PMDD), Oral contraceptive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Jan 2009 (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 purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: EE20/DRSP(YAZ, BAY86-5300) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of Premenstrual Dysphoric Disorder (PMDD)
Key exclusion criteria (5 listed)
- Any formal psychotherapeutic counselling within 1 month before the screening visit (Visit 1) or used medication for Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) including, but not limited to hormones, bromocriptine, GnRH agonists, vitamin B6 (>100 mg), calcium supplements (> 1500 mg/day), anxiolytics and antidepressants during the 3 month period prior to Visit 1
- Use of sleeping medication (including melatonin) for more than 3 days per month.
- Pregnancy or less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment
- Obesity (body mass index or BMI > 30 kg/m2)
- Hypersensitivity to any ingredient of the study drug
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)20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd | Drug | Arm 1 |
| PlaceboInert tablet | Drug | Arm 2 |
Primary outcome
The difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days before menses of the 3rd cycle in the treatment phase to average scores from the last 5 days before menses of the 2 run in cycles
Time frame: 3 cycles (1 cycle= 28 days)
6 secondary outcomes
The difference in DRSP scale scores for the 3 functional impairment items, comparing the average over the last 5 days of daily scores from the 3rd cycle in the treatment phase to the average of daily scores from the 2 run in cycles
Time frame: 3 cycles
Descriptive statistics for total DRSP scale scores (sum of the first 21 items) of the last 5 days for each of the 2 run in cycles, each of the 3 cycles in the treatment phase, and the average of the 3 cycles in the treatment phase
Time frame: 3 cylces
Descriptive statistics for change in total DRSP scale scores (sum of the first 21 items) of the last 5 days from baseline to each cycle in the treatment phase and to the average of the 3 cycles in the treatment phase
Time frame: 3 cycles
Assessment of CGI scores
Time frame: 3 cycles
Adverse events
Time frame: Whole study period
Laboratory tests
Time frame: Whole study period
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 2 Apr 2014.
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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
16 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(YAZ, BAY86-5300) in people with Premenstrual Dysphoric Disorder ( PMDD), run by Bayer at 16 sites in China.
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 1 inclusion and 5 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 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. 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 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?
The difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days before menses of the 3rd cycle in the treatment phase to average scores from the last 5 days before menses of the 2 run in cycles (time frame: 3 cycles (1 cycle= 28 days)). 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 2 Apr 2014.