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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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