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

NCT01525563 | Completed Results

• 1 other identifier: P13-282
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 32

Brief 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.

Conditions

Irregular Menstrual Cycle

Keywords

Duphaston Study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT)

  6 months

• Amount of Menstrual Bleeding From Baseline to End of Treatment

  6 months

• Evolution of Pain During Menstruation From Baseline to End of Treatment

  6 months

• Overall Patient Satisfaction

  6 months

• Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment

  6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with irregular menstrual cycle

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (32)

Site Reference ID/Investigator# 69002

Ahmedabad, 380015, India

Location

Site Reference ID/Investigator# 68995

Ahmedabad, 380051, India

Location

Site Reference ID/Investigator# 68991

Ahmedabad, 390015, India

Location

Site Reference ID/Investigator# 68990

Bangalore, 560005, India

Location

Site Reference ID/Investigator# 69503

Banglore, 560084, India

Location

Site Reference ID/Investigator# 69502

Banglore, 60032, India

Location

Site Reference ID/Investigator# 69742

Bengaluru, 560084, India

Location

Site Reference ID/Investigator# 69743

Bengaluru, India

Location

Site Reference ID/Investigator# 69324

Chennai, 600 082, India

Location

Site Reference ID/Investigator# 68994

Chennai, 600001, India

Location

Site Reference ID/Investigator# 68407

Chennai, 600002, India

Location

Site Reference ID/Investigator# 68405

Delhi, 110033, India

Location

Site Reference ID/Investigator# 68402

Delhi, 110059, India

Location

Site Reference ID/Investigator# 69505

Hyderabad, 500 014, India

Location

Site Reference ID/Investigator# 69683

Hyderabad, 500016, India

Location

Site Reference ID/Investigator# 69682

Hyderabad, 500072, India

Location

Site Reference ID/Investigator# 69000

Hyderabad, 500074, India

Location

Site Reference ID/Investigator# 69005

Jaipur, 302019, India

Location

Site Reference ID/Investigator# 68410

Jaipur, 302020, India

Location

Site Reference ID/Investigator# 68414

Jaipur, 302020, India

Location

Site Reference ID/Investigator# 68999

Jaipur, 305004, India

Location

Site Reference ID/Investigator# 73773

Mumbai, 25, India

Location

Site Reference ID/Investigator# 68993

Mumbai, 400 055, India

Location

Site Reference ID/Investigator# 69007

Mumbai, 400052, India

Location

Site Reference ID/Investigator# 69004

Mumbai, 400058, India

Location

Site Reference ID/Investigator# 69506

Mumbai, 400703, India

Location

Site Reference ID/Investigator# 68996

Mumbai, 401101, India

Location

Site Reference ID/Investigator# 69006

New Delhi, 110058, India

Location

Site Reference ID/Investigator# 69009

Pune, 411004, India

Location

Site Reference ID/Investigator# 69010

Pune, 411015, India

Location

Site Reference ID/Investigator# 68412

Pune, 411027, India

Location

Site Reference ID/Investigator# 68989

Pune, 411028, India

Location

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Associate Director Clinical Services
• Organization: Abbott

taco.baardman@abbott.com

Study Officials

• Rashmi Hegde, MD-DCh

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 29, 2014
• Results First Posted: December 29, 2014

Record last verified: 2014-12

Locations

IN (32)