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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01525563
First received: February 1, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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, assuming 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.


Condition
Irregular Menstrual Cycle

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Percentage of patients reporting a regular cycle [ Time Frame: 1-8 months ] [ Designated as safety issue: No ]
    Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.


Secondary Outcome Measures:
  • Mean cycle duration (in days) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Amount of menstrual bleeding [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Assessment of average number of pads changed per day at baseline and at the end of treatment.

  • Pain during menstruation [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Pain during menstruation (on four point severity scale: nil, mild, moderate, severe) from cessation of treatment to end follow up, by assessing percentage of patients in each category at end of treatment and at the end of follow up.

  • Overall patient satisfaction [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Overall patient satisfaction will be assessed (on four point scale: excellent, good, fair and poor) at the end of treatment.


Enrollment: 1000
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with irregular menstrual cycle

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525563

Locations
India
Site Reference ID/Investigator# 68991
Ahmedabad, India, 390015
Site Reference ID/Investigator# 68995
Ahmedabad, India, 380051
Site Reference ID/Investigator# 69002
Ahmedabad, India, 380015
Site Reference ID/Investigator# 68990
Bangalore, India, 560005
Site Reference ID/Investigator# 69742
Bangalore -84, India, 560084
Site Reference ID/Investigator# 69743
Bangalore 34, India
Site Reference ID/Investigator# 69503
Banglore, India, 560084
Site Reference ID/Investigator# 69502
Banglore, India, 60032
Site Reference ID/Investigator# 68994
Chennai, India, 600001
Site Reference ID/Investigator# 69324
Chennai, India, 600 082
Site Reference ID/Investigator# 68407
Chennai, India, 600002
Site Reference ID/Investigator# 68405
Delhi, India, 110033
Site Reference ID/Investigator# 68402
Delhi, India, 110059
Site Reference ID/Investigator# 69000
Hyderabad, India, 500074
Site Reference ID/Investigator# 69505
Hyderabad, India, 500 014
Site Reference ID/Investigator# 69682
Hyderabad, India, 500072
Site Reference ID/Investigator# 69683
Hyderabad, India, 500016
Site Reference ID/Investigator# 69005
Jaipur, India, 302019
Site Reference ID/Investigator# 68999
Jaipur, India, 305004
Site Reference ID/Investigator# 68410
Jaipur, India, 302020
Site Reference ID/Investigator# 68414
Jaipur, India, 302020
Site Reference ID/Investigator# 68996
Mumbai, India, 401101
Site Reference ID/Investigator# 69004
Mumbai, India, 400058
Site Reference ID/Investigator# 73773
Mumbai, India, 25
Site Reference ID/Investigator# 69007
Mumbai, India, 400052
Site Reference ID/Investigator# 69506
Mumbai, India, 400703
Site Reference ID/Investigator# 68993
Mumbai, India, 400 055
Site Reference ID/Investigator# 69006
New Delhi, India, 110058
Site Reference ID/Investigator# 69009
Pune, India, 411004
Site Reference ID/Investigator# 68989
Pune, India, 411028
Site Reference ID/Investigator# 68412
Pune, India, 411027
Site Reference ID/Investigator# 69010
Pune, India, 411015
Sponsors and Collaborators
Abbott
Investigators
Study Director: Rashmi Hegde, MD-DCh Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01525563     History of Changes
Other Study ID Numbers: P13-282
Study First Received: February 1, 2012
Last Updated: January 27, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by Abbott:
Duphaston Study

Additional relevant MeSH terms:
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014