Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01711216
First received: August 22, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan and Uzbekistan 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 miscarriage, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. There are limited data regarding dydrogesterone's role in achieving cycle regularization from post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in a post-marketing setting after cessation of treatment and whether the persistence, if any, is related to the duration of dydrogesterone therapy. Hence, in this observational program, the goal is to observe 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: A Post-Marketing, Prospective, Multicenter, Observational Program: Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Number of dydrogesterone therapy cycles received against number of months of maintained regular cycles in follow-up [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    To determine relationship between treatment duration (number of cycles of dydrogesterone treatment received) and persistence (number of months until when regular cycles are maintained after cessation of dydrogesterone therapy)


Secondary Outcome Measures:
  • Proportion of patients reporting at least one regular cycle over the treatment period [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles

  • Change of cycle duration from baseline to end of treatment in days in group of patients with polymenorrhea [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
    Polymenorrhea is defined as cycle duration < 21 days

  • Change of cycle duration from baseline to end of treatment in days in group of patients with oligomenorrhea (i.e., cycle duration > 35 days) [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
    Oligomenorrhea is defined as cycle duration > 35 days

  • Change of duration of menstrual bleeding from baseline to end of treatment in days in group of patients with polymenorrhea [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
    Polymenorrhea is defined as cycle duration < 21 days

  • Change of duration of menstrual bleeding from baseline to end of treatment in days in group of patients with oligomenorrhea [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
    Oligomenorrhea is defined as cycle duration > 35 days

  • Change of pain intensity during menstruation from baseline to end of treatment [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
    Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain

  • Change of intensity of anxiety from baseline to the end of treatment [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
    Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety

  • Patient satisfaction with the treatment [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied. Proportion of patients in each category at the end of treatment will be assessed

  • Overall clinical response on treatment assessed by physician [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response. Proportion of patients in each category at the end of treatment will be assessed

  • Proportion of patients with 3 consecutive regular cycles out of total number of patients who had achieved cycle regularization at the end of treatment period [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive

  • Proportion of patients with 6 consecutive regular cycles out of total number of patients who had achieved cycle regularization at the end of treatment period [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive

  • Change of duration of menstrual bleeding in days in group of patients with polymenorrhea [ Time Frame: From 1 month to 12 months ] [ Designated as safety issue: No ]
    Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days

  • Change of duration of menstrual bleeding in days in group of patients with oligomenorrhea [ Time Frame: From 1 month to 12 months ] [ Designated as safety issue: No ]
    Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days

  • Change of pain intensity during menstruation [ Time Frame: From 1 month to 12 months ] [ Designated as safety issue: No ]
    Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain

  • Change of intensity of anxiety [ Time Frame: From 1 month to 12 months ] [ Designated as safety issue: No ]
    Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety

  • Time to relapse [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Time to relapse is defined as cycle duration <21 days or >35 days


Estimated Enrollment: 1000
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
women received dydrogesterone for irregular menstrual cycle
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician

Detailed Description:

The program is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing program. Being an observational program, the assignment of patients to dydrogesterone therapy will not be decided with an intention to include patients in the program, but will be guided as per standard clinical practice of the treating physician. Hence the prescribing of dydrogesterone will be clearly separate from the decision to include patients in this program. All dydrogesterone prescriptions will be made in accordance with locally approved package insert for dydrogesterone.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women with irregular menstrual cycle due to progesterone deficiency

Criteria

Inclusion Criteria

  • Women aged 18-40 years
  • Irregular menstrual cycle due to progesterone deficiency for at least 3 months
  • Dydrogesterone prescribed in accordance with locally approved package insert
  • Signed written authorization to provide data for the program

Exclusion Criteria

  • Known hypersensitivity to the active ingredient or excipients
  • Known or suspected progesterone-dependent neoplasms
  • Vaginal bleeding of unknown etiology
  • Administration of oral contraceptives
  • Any other condition that precludes use of dydrogesterone in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)
  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: NCT01711216

  Show 66 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Claire Pexman-Fieth, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01711216     History of Changes
Other Study ID Numbers: P13-688
Study First Received: August 22, 2012
Last Updated: June 4, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Kazakhstan: Ministry of Public Health
Uzbekistan: Ministry of Health

Keywords provided by Abbott:
Dydrogesterone
Irregular Menstrual Cycle
Progestins

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 August 21, 2014