MedTrace Logo

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

NCT01525563 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2014-12-29

Study results available
· View outcomes & findings →

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

Sponsors & Collaborators

Principal Investigators

  • Rashmi Hegde, MD-DCh · Abbott

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01525563 on ClinicalTrials.gov