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

November 23, 2015 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Aktobe, Kazakhstan, 030000
        • Site reference ID/Investiagor# 82286
      • Aktobe, Kazakhstan, 030000
        • Site reference ID/Investiagor# 82287
      • Aktobe, Kazakhstan, 030000
        • Site reference ID/Investigator# 101795
      • Aktobe, Kazakhstan, 030000
        • Site reference ID/Investigator# 101799
      • Aktobe, Kazakhstan, 030000
        • Site reference ID/Investigator# 82279
      • Aktobe, Kazakhstan, 030019
        • Site reference ID/Investigator# 101798
      • Almaty, Kazakhstan, 050000
        • Site reference ID/Investiagor# 82281
      • Almaty, Kazakhstan, 050009
        • Site reference ID/Investigator# 82293
      • Astana, Kazakhstan, 010000
        • Site reference ID/Investigator# 101796
      • Astana, Kazakhstan, 010000
        • Site reference ID/Investigator# 101797
      • Astana, Kazakhstan, 010000
        • Site reference ID/Investigator# 82277
      • Astana, Kazakhstan, 010000
        • Site reference ID/Investigator# 82299
      • Astana, Kazakhstan, 010000
        • Site reference ID/Investigator# 82300
      • Astana, Kazakhstan, 10000
        • Site reference ID/Investigator# 82301
      • Shymkent, Kazakhstan, 160000
        • Site reference ID/Investiagor# 82282
      • Shymkent, Kazakhstan, 160000
        • Site reference ID/Investigator# 82275
      • Shymkent, Kazakhstan, 160000
        • Site reference ID/Investigator# 82288
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
        • Site reference ID/Investigator# 82035
      • Irkutsk, Russian Federation, 664003
        • Site reference ID/Investigaotr# 76702
      • Kazan, Russian Federation, 420043
        • Site reference ID/Investigator# 77753
      • Kemerovo, Russian Federation, 650029
        • Site reference ID/Investigaotr# 76704
      • Krasnodar, Russian Federation, 350063 RF
        • Site reference ID/Investigator# 76701
      • Moscow, Russian Federation, 101000
        • Site reference ID/Investigaot# 88537
      • Moscow, Russian Federation, 117997
        • Site reference ID/Investigaotr# 76708
      • Moscow, Russian Federation, 121243
        • Site reference ID/Investigator# 76700
      • Moscow, Russian Federation, 127018
        • Site reference ID/Investigator# 87013
      • Moscow, Russian Federation, 127473
        • Site reference ID/Investigaot# 88535
      • Nizhniy Novgorod, Russian Federation, 603057
        • Site reference ID/Investigaot# 88514
      • Novosibirsk, Russian Federation
        • Site reference ID/Investigator# 83633
      • St. Petersburg, Russian Federation, 194100
        • Site reference ID/Investigaot# 88536
      • St. Petersburg, Russian Federation, 194100
        • Site reference ID/Investigaotr# 76709
      • St. Petersburg, Russian Federation, 195257
        • Site reference ID/Investigator# 77754
      • Tomsk, Russian Federation, 634050
        • Site reference ID/Investigaotr# 76705
      • Tumen, Russian Federation, 625002
        • Site reference ID/Investigator# 77755
      • Volgograd, Russian Federation, 400008
        • Site reference ID/Investigator# 82036
      • Voronezh, Russian Federation, 394036
        • Site reference ID/Investigaot# 88513
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49000
        • Site reference ID/Investigaot# 75815
      • Ivano-Frankivsk, Ukraine, 76000
        • Site Reference ID/Investigator# 75816
      • Kharkiv, Ukraine, 61050
        • Site reference #/Investigator ID 77816
      • Kharkiv, Ukraine, 61075
        • Site reference ID/Investigaot# 75817
      • Kiev, Ukraine, 01034
        • Site reference ID/Investigaot# 75813
      • Kiev, Ukraine, 04112
        • Site Reference ID/Investigator# 75814
      • Lviv, Ukraine, 79032
        • Site reference ID/Investigaot# 88056
      • Mykolaiv, Ukraine, 54058
        • Site reference ID/Investigaot# 75819
      • Odesa, Ukraine, 65000
        • Site reference ID/Investigaot# 77817
      • Odesa, Ukraine, 65039
        • Site reference ID/Investigaot# 80193
      • Ternopil, Ukraine, 46020
        • Site reference ID/Investigator # 77813
      • Vinnytsia, Ukraine, 21009
        • Site reference ID/Investigaot# 75818
      • Zaporizhzhia, Ukraine, 69071
        • Site Reference ID/Investigator# 75822
  • Uzbekistan
      • Andijan, Uzbekistan, 170000
        • Site reference ID/Investigaot# 91973
      • Andijan, Uzbekistan, 170100
        • Site reference ID/Investigaot# 91974
      • Bukhara, Uzbekistan, 705000
        • Site reference ID/Investigaot# 91987
      • Fergana, Uzbekistan, 150100
        • Site reference ID/Investigaot# 91975
      • Samarkand, Uzbekistan, 140108
        • Site reference ID/Investigaot# 91986
      • Tashkent, Uzbekistan, 100007
        • Site reference ID/Investigaot# 100616
      • Tashkent, Uzbekistan, 100029
        • Site reference ID/Investigaot# 91984
      • Tashkent, Uzbekistan, 100069
        • Site reference ID/Investigaot# 91977
      • Tashkent, Uzbekistan, 100093
        • Site reference ID/Investigaot# 91981
      • Tashkent, Uzbekistan, 100093
        • Site reference ID/Investigaot# 91982
      • Tashkent, Uzbekistan, 100093
        • Site reference ID/Investigaot# 92473
      • Tashkent, Uzbekistan, 100109
        • Site reference ID/Investigaot# 91988
      • Tashkent, Uzbekistan, 100171
        • Site reference ID/Investigaot# 92474
      • Tashkent, Uzbekistan, 100206
        • Site reference ID/Investigaot# 91976
      • Tashkent, Uzbekistan, 100206
        • Site reference ID/Investigaot# 91983
      • Urgench, Uzbekistan, 220100
        • Site reference ID/Investigaot# 91980
      • Urgench, Uzbekistan, 220100
        • Site reference ID/Investigaot# 91985

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women with irregular menstrual cycle due to progesterone deficiency

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
women received dydrogesterone for irregular menstrual cycle
Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)
Time Frame: up to 6 months
up to 6 months
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period
Time Frame: Up to 6 months
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
Up to 6 months
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
Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated
From 1 month to 6 months
Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea
Time Frame: From 1 month to 6 months
Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated
From 1 month to 6 months
Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea
Time Frame: From 1 month to 6 months
Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days
From 1 month to 6 months
Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea
Time Frame: From 1 month to 6 months
Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days
From 1 month to 6 months
Change of Pain Intensity During Menstruation From Baseline to End of Treatment
Time Frame: From 1 month to 6 months
Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain
From 1 month to 6 months
Change of Intensity of Anxiety From Baseline to the End of Treatment
Time Frame: From 1 month to 6 months
Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety
From 1 month to 6 months
Patient Satisfaction With the Treatment
Time Frame: Up to 6 months
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.
Up to 6 months
Overall Clinical Response on Treatment Assessed by Physician
Time Frame: Up to 6 months
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.
Up to 6 months
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
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
Up to 9 months
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
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
Up to 12 months
Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea
Time Frame: From 1 month to 12 months
Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days
From 1 month to 12 months
Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea
Time Frame: From 1 month to 12 months
Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days
From 1 month to 12 months
Change of Pain Intensity During Menstruation
Time Frame: From 1 month to 12 months
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
From 1 month to 12 months
Change of Intensity of Anxiety
Time Frame: From 1 month to 12 months
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
From 1 month to 12 months
Time to Relapse
Time Frame: Up to 6 months or longer after ended treatment
The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.
Up to 6 months or longer after ended treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Claire Pexman-Fieth, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 22, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P13-688

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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