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

NCT ID: NCT01711216

Last Updated: 2015-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Irregular Menstrual Cycle

Keywords

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Dydrogesterone Irregular Menstrual Cycle Progestins

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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women received dydrogesterone for irregular menstrual cycle

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

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Pexman-Fieth, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site reference ID/Investiagor# 82286

Aktobe, , Kazakhstan

Site Status

Site reference ID/Investiagor# 82287

Aktobe, , Kazakhstan

Site Status

Site reference ID/Investigator# 101795

Aktobe, , Kazakhstan

Site Status

Site reference ID/Investigator# 101799

Aktobe, , Kazakhstan

Site Status

Site reference ID/Investigator# 82279

Aktobe, , Kazakhstan

Site Status

Site reference ID/Investigator# 101798

Aktobe, , Kazakhstan

Site Status

Site reference ID/Investiagor# 82281

Almaty, , Kazakhstan

Site Status

Site reference ID/Investigator# 82293

Almaty, , Kazakhstan

Site Status

Site reference ID/Investigator# 101796

Astana, , Kazakhstan

Site Status

Site reference ID/Investigator# 101797

Astana, , Kazakhstan

Site Status

Site reference ID/Investigator# 82277

Astana, , Kazakhstan

Site Status

Site reference ID/Investigator# 82299

Astana, , Kazakhstan

Site Status

Site reference ID/Investigator# 82300

Astana, , Kazakhstan

Site Status

Site reference ID/Investigator# 82301

Astana, , Kazakhstan

Site Status

Site reference ID/Investiagor# 82282

Shymkent, , Kazakhstan

Site Status

Site reference ID/Investigator# 82275

Shymkent, , Kazakhstan

Site Status

Site reference ID/Investigator# 82288

Shymkent, , Kazakhstan

Site Status

Site reference ID/Investigaotr# 76702

Irkutsk, , Russia

Site Status

Site reference ID/Investigator# 77753

Kazan', , Russia

Site Status

Site reference ID/Investigaotr# 76704

Kemerovo, , Russia

Site Status

Site reference ID/Investigator# 76701

Krasnodar, , Russia

Site Status

Site reference ID/Investigaot# 88537

Moscow, , Russia

Site Status

Site reference ID/Investigaotr# 76708

Moscow, , Russia

Site Status

Site reference ID/Investigator# 76700

Moscow, , Russia

Site Status

Site reference ID/Investigator# 87013

Moscow, , Russia

Site Status

Site reference ID/Investigaot# 88535

Moscow, , Russia

Site Status

Site reference ID/Investigaot# 88514

Nizhny Novgorod, , Russia

Site Status

Site reference ID/Investigator# 83633

Novosibirsk, , Russia

Site Status

Site reference ID/Investigaot# 88536

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigaotr# 76709

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigator# 77754

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigaotr# 76705

Tomsk, , Russia

Site Status

Site reference ID/Investigator# 77755

Tyumen, , Russia

Site Status

Site reference ID/Investigator# 82036

Volgograd, , Russia

Site Status

Site reference ID/Investigaot# 88513

Voronezh, , Russia

Site Status

Site reference ID/Investigator# 82035

Yekaterinburg, , Russia

Site Status

Site reference ID/Investigaot# 75815

Dnipropetrovsk, , Ukraine

Site Status

Site Reference ID/Investigator# 75816

Ivano-Frankivsk, , Ukraine

Site Status

Site reference #/Investigator ID 77816

Kharkiv, , Ukraine

Site Status

Site reference ID/Investigaot# 75817

Kharkiv, , Ukraine

Site Status

Site reference ID/Investigaot# 75813

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 75814

Kiev, , Ukraine

Site Status

Site reference ID/Investigaot# 88056

Lviv, , Ukraine

Site Status

Site reference ID/Investigaot# 75819

Mykolaiv, , Ukraine

Site Status

Site reference ID/Investigaot# 77817

Odesa, , Ukraine

Site Status

Site reference ID/Investigaot# 80193

Odesa, , Ukraine

Site Status

Site reference ID/Investigator # 77813

Ternopil, , Ukraine

Site Status

Site reference ID/Investigaot# 75818

Vinnytsia, , Ukraine

Site Status

Site Reference ID/Investigator# 75822

Zaporizhzhia, , Ukraine

Site Status

Site reference ID/Investigaot# 91973

Andijan, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91974

Andijan, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91987

Bukhara, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91975

Fergana, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91986

Samarkand, , Uzbekistan

Site Status

Site reference ID/Investigaot# 100616

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91984

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91977

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91981

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91982

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 92473

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91988

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 92474

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91976

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91983

Tashkent, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91980

Urgench, , Uzbekistan

Site Status

Site reference ID/Investigaot# 91985

Urgench, , Uzbekistan

Site Status

Countries

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Kazakhstan Russia Ukraine Uzbekistan

Other Identifiers

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P13-688

Identifier Type: -

Identifier Source: org_study_id