MenorrhagiaNCT01647360
Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment
An observational study of Menorrhagia and Metrorrhagia, run by Abbott at 20 sites in Pakistan.
Trial summary
Dydrogesterone is a retroprogesterone with a molecular structure similar to natural progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic activity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menorrhagia, Metrorrhagia
- How many people
- 210 participants
- Where
- 20 sitesPakistan
- Study dates
- Jun 2012to May 2013
- Phase
- Observational
- 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
Study population: Women with heavy menstrual bleeding
Who may be able to join
- Females aged 18 to 45 years
- Subjects presenting with Heavy Menstrual Bleeding (HMB)
- Subjects with Pictorial Blood Assessment Chart (PBAC) score of 100 or more
- Subjects will be treated with dydrogesterone in accordance to the local label after enrollment in the trial
Who cannot join
- Subjects with structural or organic pathology as an underlying cause of HMB.
- Subjects with hypersensitivity to dydrogesterone
- Known or suspected progestogen dependent neoplasms
- Subjects with vaginal bleeding who have not been screened for organic or structural pathology as an underlying cause
- Subjects with acute or chronic liver disease
- Patients with depressive illness
Show all 10Show fewer
- Subjects who are known to have rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Nursing mothers
- Use of any other medication for uterine bleeding (including but not limited to progesterone, oral contraceptive pills, tranexamic acid etc)
- Use of Non-Steroidal Anti inflammatory Drugs (NSAIDs)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Pakistan20 sites
Site reference ID/Investigator# 79836
Islamabad, Federal Capital, 44000
Site Reference ID/Investigator# 77674
Karachi, Sindh, 74000
Site Reference ID/Investigator# 77675
Karachi, Sindh, 74000
Site reference ID/Investigator# 77676
Karachi, Sindh, 74000
Site Reference ID/Investigator# 77677
Karachi, Sindh, 74000
Site Reference ID/Investigator# 77680
Karachi, Sindh, 74000
Site Reference ID/Investigator# 77681
Karachi, Sindh, 74000
Site reference ID/Investigator # 77690
Lahore, Punjab, 54000
Site Reference ID/Investigator# 77691
Lahore, Punjab, 54000
Site reference ID/Investigator# 77694
Lahore, Punjab, 54000
Site Reference ID/Investigator# 77695
Lahore, Punjab, 54000
Site Reference ID/Investigator# 77696
Lahore, Punjab, 54000
Site reference ID/Investigator# 77698
Lahore, Punjab, 54000
Site Reference ID/Investigator# 77699
Lahore, Punjab, 54000
Site Reference ID/Investigator# 77686
Multan, Punjab, 60000
Site Reference ID/Investigator# 77687
Multan, Punjab, 60000
Site Reference ID/Investigator# 77684
Multan, Punjab, 6000
Site Reference ID/Investigator# 77689
Multan, Punjab, 6000
Site reference ID/Investigator # 77693
Rawalpindi, Punjab, 46000
Site reference ID/Investigator# 79834
Rawalpindi, Punjab, 46000
About this study
Official title: A Post- Marketing, Prospective,Multicenter, Observational Program: Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment
Dydrogesterone is a retroprogesterone with a molecular structure similar to natural progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.
In this study, women suffering from menorrhagia and who are treated with dydrogesterone will be observed for impact on QoL with the reduction in severity of bleeding.
- Conditions
- Menorrhagia, Metrorrhagia
- Keywords
- Metrorrhagia, Menorrhagia
- Medical subject headings
- Menorrhagia, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with Heavy Menstrual Bleeding (HMB) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D Quality of Life questionnaire
The EQ-5D assesses five dimensions of HRQOL: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is measured on a three-point ordinal scale where a higher score corresponds to a worse health state (no limitation, some limitation, and greatest limitation in HRQOL). This will be evaluated at baseline and then at each follow up visit to see impact on quality of life.
Measured: 3 months
Secondary outcomes (2)
Pictorial Blood Assessment Chart (PBAC) score
PBAC score of 100 or more corresponds with heavy menstrual bleeding. PBAC score will be assessed at each visit to see any improvement.
Measured: 3 months
Menstrual Cycle Diary
Change in the nature of menstruation will be taken into account based on the subjects' perception as recorded on the Menstrual Cycle Diary.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raeef Ahmed, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647360
- Sponsor's protocol ID
- P13-699
- Status last verified
- May 2013
- First submitted
- 19 Jul 2012
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post- Marketing, Prospective,Multicenter, Observational Program: Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment
- ClinicalTrials.gov ID
- NCT01647360
- Acronym / sponsor ID
- P13-699
- Conditions
- Menorrhagia, Metrorrhagia
- Keywords
- Metrorrhagia, Menorrhagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Jul 2012 (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.
Dydrogesterone is a retroprogesterone with a molecular structure similar to natural progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.
In this study, women suffering from menorrhagia and who are treated with dydrogesterone will be observed for impact on QoL with the reduction in severity of bleeding.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with Heavy Menstrual Bleeding (HMB) | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with heavy menstrual bleeding
Key inclusion criteria (4 listed)
- Females aged 18 to 45 years
- Subjects presenting with Heavy Menstrual Bleeding (HMB)
- Subjects with Pictorial Blood Assessment Chart (PBAC) score of 100 or more
- Subjects will be treated with dydrogesterone in accordance to the local label after enrollment in the trial
Key exclusion criteria (10 listed)
- Subjects with structural or organic pathology as an underlying cause of HMB.
- Subjects with hypersensitivity to dydrogesterone
- Known or suspected progestogen dependent neoplasms
- Subjects with vaginal bleeding who have not been screened for organic or structural pathology as an underlying cause
- Subjects with acute or chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EQ-5D Quality of Life questionnaire
Time frame: 3 months
The EQ-5D assesses five dimensions of HRQOL: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is measured on a three-point ordinal scale where a higher score corresponds to a worse health state (no limitation, some limitation, and greatest limitation in HRQOL). This will be evaluated at baseline and then at each follow up visit to see impact on quality of life.
2 secondary outcomes
Pictorial Blood Assessment Chart (PBAC) score
Time frame: 3 months
Menstrual Cycle Diary
Time frame: 3 months
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 29 May 2013.
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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.
Raeef Ahmed, MD study director
Abbott
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia and Metrorrhagia, run by Abbott at 20 sites in Pakistan.
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 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 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Pakistan. 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.
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?
EQ-5D Quality of Life questionnaire (time frame: 3 months). 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 29 May 2013.