Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study

Irregular Menstrual Cycle Clinical Trial

Official title:

Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525563
• Other study ID #: P13-282
• Status: Completed
• Phase: N/A
• First received: February 1, 2012
• Last updated: December 17, 2014
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical 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, 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.

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:

A. 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.

B. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Irregular Menstrual Cycle

Locations

Country	Name	City	State
India	Site Reference ID/Investigator# 68991	Ahmedabad
India	Site Reference ID/Investigator# 68995	Ahmedabad
India	Site Reference ID/Investigator# 69002	Ahmedabad
India	Site Reference ID/Investigator# 68990	Bangalore
India	Site Reference ID/Investigator# 69742	Bangalore -84
India	Site Reference ID/Investigator# 69743	Bangalore 34
India	Site Reference ID/Investigator# 69502	Banglore
India	Site Reference ID/Investigator# 69503	Banglore
India	Site Reference ID/Investigator# 68407	Chennai
India	Site Reference ID/Investigator# 68994	Chennai
India	Site Reference ID/Investigator# 69324	Chennai
India	Site Reference ID/Investigator# 68402	Delhi
India	Site Reference ID/Investigator# 68405	Delhi
India	Site Reference ID/Investigator# 69000	Hyderabad
India	Site Reference ID/Investigator# 69505	Hyderabad
India	Site Reference ID/Investigator# 69682	Hyderabad
India	Site Reference ID/Investigator# 69683	Hyderabad
India	Site Reference ID/Investigator# 68410	Jaipur
India	Site Reference ID/Investigator# 68414	Jaipur
India	Site Reference ID/Investigator# 68999	Jaipur
India	Site Reference ID/Investigator# 69005	Jaipur
India	Site Reference ID/Investigator# 68993	Mumbai
India	Site Reference ID/Investigator# 68996	Mumbai
India	Site Reference ID/Investigator# 69004	Mumbai
India	Site Reference ID/Investigator# 69007	Mumbai
India	Site Reference ID/Investigator# 69506	Mumbai
India	Site Reference ID/Investigator# 73773	Mumbai
India	Site Reference ID/Investigator# 69006	New Delhi
India	Site Reference ID/Investigator# 68412	Pune
India	Site Reference ID/Investigator# 68989	Pune
India	Site Reference ID/Investigator# 69009	Pune
India	Site Reference ID/Investigator# 69010	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	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.	6 months	No
Secondary	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).	6 months	No
Secondary	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.	6 months	No
Secondary	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).	6 months	No
Secondary	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.	6 months	No
Secondary	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.	6 months	No