Irregular Menstrual CycleNCT01525563
Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study
An observational study of Irregular Menstrual Cycle, run by Abbott at 32 sites in India.
Trial summary
In India Duphaston is approved and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual abortion, infertility due to luteal insufficiency… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Irregular Menstrual Cycle
- How many people
- 1,000 participants
- Where
- 32 sitesIndia
- Study dates
- Apr 2012to Dec 2013
- Phase
- Observational
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with irregular menstrual cycle
Who may be able to join
- Women aged 18 years or older
- Suffering from irregular menstrual cycle for at least 3 months and for whom the physician decides to prescribe Duphaston, in accordance with locally approved package insert
- Patients willing to sign written authorization to provide data for the study
Who cannot join
- Patients having known hypersensitivity to the active ingredient or excipients
- Patients having known or suspected progesterone-dependent neoplasms
- Patients having vaginal bleeding of unknown etiology
- Patients taking oral contraceptives
- Pregnant and lactating patients
- Any other condition that precludes use of Duphaston in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with history of liver disease, porphyria or depression)
- Patients not willing to sign written authorization for data release consent form
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
India32 sites
Site Reference ID/Investigator# 69002
Ahmedabad, 380015
Site Reference ID/Investigator# 68995
Ahmedabad, 380051
Site Reference ID/Investigator# 68991
Ahmedabad, 390015
Site Reference ID/Investigator# 68990
Bangalore, 560005
Site Reference ID/Investigator# 69503
Banglore, 560084
Site Reference ID/Investigator# 69502
Banglore, 60032
Site Reference ID/Investigator# 69742
Bengaluru, 560084
Site Reference ID/Investigator# 69743
Bengaluru
Site Reference ID/Investigator# 69324
Chennai, 600 082
Site Reference ID/Investigator# 68994
Chennai, 600001
Site Reference ID/Investigator# 68407
Chennai, 600002
Site Reference ID/Investigator# 68405
Delhi, 110033
Site Reference ID/Investigator# 68402
Delhi, 110059
Site Reference ID/Investigator# 69505
Hyderabad, 500 014
Site Reference ID/Investigator# 69683
Hyderabad, 500016
Site Reference ID/Investigator# 69682
Hyderabad, 500072
Site Reference ID/Investigator# 69000
Hyderabad, 500074
Site Reference ID/Investigator# 69005
Jaipur, 302019
Site Reference ID/Investigator# 68410
Jaipur, 302020
Site Reference ID/Investigator# 68414
Jaipur, 302020
Site Reference ID/Investigator# 68999
Jaipur, 305004
Site Reference ID/Investigator# 73773
Mumbai, 25
Site Reference ID/Investigator# 68993
Mumbai, 400 055
Site Reference ID/Investigator# 69007
Mumbai, 400052
Site Reference ID/Investigator# 69004
Mumbai, 400058
Site Reference ID/Investigator# 69506
Mumbai, 400703
Site Reference ID/Investigator# 68996
Mumbai, 401101
Site Reference ID/Investigator# 69006
New Delhi, 110058
Site Reference ID/Investigator# 69009
Pune, 411004
Site Reference ID/Investigator# 69010
Pune, 411015
Site Reference ID/Investigator# 68412
Pune, 411027
Site Reference ID/Investigator# 68989
Pune, 411028
About this study
In India Duphaston is approved and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual abortion, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. One Indian study reported normalization of the cycle in 91.6% of women with menstrual problems after three cycles of therapy with dydrogesterone 10 mg given from 11th to the 25th day of the menstrual cycle. The mean cycle duration during dydrogesterone therapy in this study was noted to be 28.8 days, in contrast to 17.9 days (in the polymenorrhea group) and 50.6 days (in the oligomenorrhea group) before therapy. Furthermore, dydrogesterone also decreased the amount and duration of menstrual bleeding in this study.
However, there are limited data regarding Duphaston's role in achieving cycle regularization from post-marketing settings. Moreover, it is not well-known if the effect of Duphaston therapy persists after cessation of treatment and whether the persistent effect, if any, is related to the duration of Duphaston therapy.
Hence, in this observational study, given that (based on previous clinical studies as mentioned above) Duphaston plays a role in menstrual irregularities treatment, the goal is to tease out the possible implications of such treatment in terms of treatment length and response pattern.
Read the detailed description
Primary objective:
- To determine percentage of patients reporting a regular cycle (defined as cycle duration between 21 to 35 days, inclusive) at the end of treatment period.
Secondary objectives:
- For all patients:
- To describe evolution of cycle duration from baseline to end of treatment by assessing mean cycle duration (in days) at baseline, separately in polymenorrhea, (i.e., cycle duration \< 21 days) and oligomenorrhea (i.e., cycle duration \> 35 days) groups, and at the end of treatment.
- To describe evolution of duration of menstrual bleeding from baseline to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment.
- To describe evolution of amount of menstrual bleeding from baseline to end of treatment, by assessing average number of pads changed per day at baseline and at the end of treatment.
- To describe evolution of pain during menstruation (on a 11 point Likert Scale where 0 means no pain and 10 means worst pain) ) from baseline to end of treatment, by assessing mean and standard deviation of pain scores at baseline and at the end of treatment.
- To describe overall patient satisfaction (on a 5 point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied) at the end of treatment, by assessing percentages of patients in each category at the end of treatment.
- To describe overall clinical response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) ) at the end of treatment by assessing percentages of patients in each category at the end of treatment.
- For patients who had achieved regular cycle at the end of treatment:
- To determine the percentage of patients still experiencing regular cycle (i.e., duration 21-35 days, inclusive) at the end of follow up period, out of total number of patients who had achieved cycle regularization at the end of treatment period.
- To determine median time to relapse (defined as cycle duration \< 21 days or \> 35 days) during the follow up period, for patients who had achieved regular cycle at the end of treatment, using Kaplan Meier's method to graphically plot time after cessation of treatment versus percentage of patients still having regular cycles.
- To determine any correlation between treatment duration (number of cycles of Duphaston treatment received) and persistence of effect (number of months until when regular cycles are maintained after cessation of Duphaston therapy), using linear regression analysis model.
- To describe evolution of duration of menstrual bleeding from cessation of treatment to end follow up, by assessing mean duration of menstrual bleeding (in days) at end of treatment and at the end of follow up.
- To describe evolution of amount of menstrual bleeding from cessation of treatment to end follow up, by assessing average number of pads changed per day at end of treatment and at the end of follow up.
- To describe evolution of pain during menstruation (on a 11 point Likert Scale where 0 means no pain and 10 means worst pain) from cessation of treatment to end follow up, by assessing mean and standard deviation of pain scores at end of treatment and at the end of follow up.
- Conditions
- Irregular Menstrual Cycle
- Keywords
- Duphaston Study
- Medical subject headings
- Menstruation Disturbances
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 |
|---|---|---|
| Subjects with irregular Menstrual cycle | Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Reporting a Regular Cycle
Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.
Measured: 6 months
Secondary outcomes (6)
Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT)
The evolution of cycle duration from baseline to EOT was assessed by mean cycle duration (in days) at baseline, separately in polymenorrhea and oligomenorrhea groups, and at the EOT. The patients were included in polymenorrhea group in case the cycle duration at baseline was less than 21 days and in oligomenorrhea group in case the cycle duration at baseline was greater than 35 days.
Measured: 6 months
Amount of Menstrual Bleeding From Baseline to End of Treatment
Assessment of average number of pads changed per day at baseline and at the end of treatment (EOT).
Measured: 6 months
Evolution of Pain During Menstruation From Baseline to End of Treatment
The scores for pain during menstruation were recorded on 11-point Likert scale on baseline and end of treatment where 0 means no pain, and 10 means worst pain.
Measured: 6 months
Overall Patient Satisfaction
The overall patient satisfaction was recorded on a 5 point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied).
Measured: 6 months
Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment
To observe the evolution of duration of menstrual bleeding from baseline to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment.
Measured: 6 months
Overall Clinical Response
Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2013
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.
- Other trials for Irregular Menstrual CycleStudies 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
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rashmi Hegde, MD-DCh, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525563
- Sponsor's protocol ID
- P13-282
- Status last verified
- Dec 2014
- First submitted
- 1 Feb 2012
- Last updated
- 29 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT01525563
- Acronym / sponsor ID
- P13-282
- Conditions
- Irregular Menstrual Cycle
- Keywords
- Duphaston Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Posted 29 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In India Duphaston is approved and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual abortion, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. One Indian study reported normalization of the cycle in 91.6% of women with menstrual problems after three cycles of therapy with dydrogesterone 10 mg given from 11th to the 25th day of the menstrual cycle. The mean cycle duration during dydrogesterone therapy in this study was noted to be 28.8 days, in contrast to 17.9 days (in the polymenorrhea group) and 50.6 days (in the oligomenorrhea group) before therapy. Furthermore, dydrogesterone also decreased the amount and duration of menstrual bleeding in this study.
However, there are limited data regarding Duphaston's role in achieving cycle regularization from post-marketing settings. Moreover, it is not well-known if the effect of Duphaston therapy persists after cessation of treatment and whether the persistent effect, if any, is related to the duration of Duphaston therapy.
Hence, in this observational study, given that (based on previous clinical studies as mentioned above) Duphaston plays a role in menstrual irregularities treatment, the goal is to tease out the possible implications of such treatment in terms of treatment length and response pattern.
Detailed description
Primary objective:
- To determine percentage of patients reporting a regular cycle (defined as cycle duration between 21 to 35 days, inclusive) at the end of treatment period.
Secondary objectives:
- For all patients:
- To describe evolution of cycle duration from baseline to end of treatment by assessing mean cycle duration (in days) at baseline, separately in polymenorrhea, (i.e., cycle duration \< 21 days) and oligomenorrhea (i.e., cycle duration \> 35 days) groups, and at the end of treatment.
- To describe evolution of duration of menstrual bleeding from baseline to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment.
- To describe evolution of amount of menstrual bleeding from baseline to end of treatment, by assessing average number of pads changed per day at baseline and at the end of treatment.
- To describe evolution of pain during menstruation (on a 11 point Likert Scale where 0 means no pain and 10 means worst pain) ) from baseline to end of treatment, by assessing mean and standard deviation of pain scores at baseline and at the end of treatment.
- To describe overall patient satisfaction (on a 5 point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied) at the end of treatment, by assessing percentages of patients in each category at the end of treatment.
- To describe overall clinical response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) ) at the end of treatment by assessing percentages of patients in each category at the end of treatment.
- For patients who had achieved regular cycle at the end of treatment:
- To determine the percentage of patients still experiencing regular cycle (i.e., duration 21-35 days, inclusive) at the end of follow up period, out of total number of patients who had achieved cycle regularization at the end of treatment period.
- To determine median time to relapse (defined as cycle duration \< 21 days or \> 35 days) during the follow up period, for patients who had achieved regular cycle at the end of treatment, using Kaplan Meier's method to graphically plot time after cessation of treatment versus percentage of patients still having regular cycles.
- To determine any correlation between treatment duration (number of cycles of Duphaston treatment received) and persistence of effect (number of months until when regular cycles are maintained after cessation of Duphaston therapy), using linear regression analysis model.
- To describe evolution of duration of menstrual bleeding from cessation of treatment to end follow up, by assessing mean duration of menstrual bleeding (in days) at end of treatment and at the end of follow up.
- To describe evolution of amount of menstrual bleeding from cessation of treatment to end follow up, by assessing average number of pads changed per day at end of treatment and at the end of follow up.
- To describe evolution of pain during menstruation (on a 11 point Likert Scale where 0 means no pain and 10 means worst pain) from cessation of treatment to end follow up, by assessing mean and standard deviation of pain scores at end of treatment and at the end of follow up.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with irregular Menstrual cycle | – | –Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with irregular menstrual cycle
Key inclusion criteria (3 listed)
- Women aged 18 years or older
- Suffering from irregular menstrual cycle for at least 3 months and for whom the physician decides to prescribe Duphaston, in accordance with locally approved package insert
- Patients willing to sign written authorization to provide data for the study
Key exclusion criteria (7 listed)
- Patients having known hypersensitivity to the active ingredient or excipients
- Patients having known or suspected progesterone-dependent neoplasms
- Patients having vaginal bleeding of unknown etiology
- Patients taking oral contraceptives
- Pregnant and lactating patients
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
Percentage of Patients Reporting a Regular Cycle
Time frame: 6 months
Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.
6 secondary outcomes
Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT)
Time frame: 6 months
Amount of Menstrual Bleeding From Baseline to End of Treatment
Time frame: 6 months
Evolution of Pain During Menstruation From Baseline to End of Treatment
Time frame: 6 months
Overall Patient Satisfaction
Time frame: 6 months
Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment
Time frame: 6 months
Overall Clinical Response
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rashmi Hegde, MD-DCh study director
Abbott
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irregular Menstrual Cycle, run by Abbott at 32 sites in India.
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 7 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 Dec 2014. 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 India. 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?
Yes. Results are posted in the registry (first posted 29 Dec 2014). 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?
Percentage of Patients Reporting a Regular Cycle (time frame: 6 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 Dec 2014.