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

NCT01711216 | Completed Results

• 1 other identifier: P13-688
• Study Type: observational
• Target: 999
• Locations: 4 countries
• Sites: 66

Brief Summary

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.

Conditions

Irregular Menstrual Cycle

Keywords

Dydrogesterone; Irregular Menstrual Cycle; Progestins

Outcome Measures

Primary Outcomes (2)

• Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)

  up to 6 months

• Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)

  up to 6 months

Secondary Outcomes (16)

• Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period

  Up to 6 months

• Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea

  From 1 month to 6 months

• Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea

  From 1 month to 6 months

• Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea

  From 1 month to 6 months

• Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea

  From 1 month to 6 months

Study Arms (1)

women received dydrogesterone for irregular menstrual cycle

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women with irregular menstrual cycle due to progesterone deficiency

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott: lead

Study Sites (66)

Site reference ID/Investiagor# 82286

Aktobe, 030000, Kazakhstan

Location

Site reference ID/Investiagor# 82287

Aktobe, 030000, Kazakhstan

Location

Site reference ID/Investigator# 101795

Aktobe, 030000, Kazakhstan

Location

Site reference ID/Investigator# 101799

Aktobe, 030000, Kazakhstan

Location

Site reference ID/Investigator# 82279

Aktobe, 030000, Kazakhstan

Location

Site reference ID/Investigator# 101798

Aktobe, 030019, Kazakhstan

Location

Site reference ID/Investiagor# 82281

Almaty, 050000, Kazakhstan

Location

Site reference ID/Investigator# 82293

Almaty, 050009, Kazakhstan

Location

Site reference ID/Investigator# 101796

Astana, 010000, Kazakhstan

Location

Site reference ID/Investigator# 101797

Astana, 010000, Kazakhstan

Location

Site reference ID/Investigator# 82277

Astana, 010000, Kazakhstan

Location

Site reference ID/Investigator# 82299

Astana, 010000, Kazakhstan

Location

Site reference ID/Investigator# 82300

Astana, 010000, Kazakhstan

Location

Site reference ID/Investigator# 82301

Astana, 10000, Kazakhstan

Location

Site reference ID/Investiagor# 82282

Shymkent, 160000, Kazakhstan

Location

Site reference ID/Investigator# 82275

Shymkent, 160000, Kazakhstan

Location

Site reference ID/Investigator# 82288

Shymkent, 160000, Kazakhstan

Location

Site reference ID/Investigaotr# 76702

Irkutsk, 664003, Russia

Location

Site reference ID/Investigator# 77753

Kazan', 420043, Russia

Location

Site reference ID/Investigaotr# 76704

Kemerovo, 650029, Russia

Location

Site reference ID/Investigator# 76701

Krasnodar, 350063 RF, Russia

Location

Site reference ID/Investigaot# 88537

Moscow, 101000, Russia

Location

Site reference ID/Investigaotr# 76708

Moscow, 117997, Russia

Location

Site reference ID/Investigator# 76700

Moscow, 121243, Russia

Location

Site reference ID/Investigator# 87013

Moscow, 127018, Russia

Location

Site reference ID/Investigaot# 88535

Moscow, 127473, Russia

Location

Site reference ID/Investigaot# 88514

Nizhny Novgorod, 603057, Russia

Location

Site reference ID/Investigator# 83633

Novosibirsk, Russia

Location

Site reference ID/Investigaot# 88536

Saint Petersburg, 194100, Russia

Location

Site reference ID/Investigaotr# 76709

Saint Petersburg, 194100, Russia

Location

Site reference ID/Investigator# 77754

Saint Petersburg, 195257, Russia

Location

Site reference ID/Investigaotr# 76705

Tomsk, 634050, Russia

Location

Site reference ID/Investigator# 77755

Tyumen, 625002, Russia

Location

Site reference ID/Investigator# 82036

Volgograd, 400008, Russia

Location

Site reference ID/Investigaot# 88513

Voronezh, 394036, Russia

Location

Site reference ID/Investigator# 82035

Yekaterinburg, 620102, Russia

Location

Site reference ID/Investigaot# 75815

Dnipropetrovsk, 49000, Ukraine

Location

Site Reference ID/Investigator# 75816

Ivano-Frankivsk, 76000, Ukraine

Location

Site reference #/Investigator ID 77816

Kharkiv, 61050, Ukraine

Location

Site reference ID/Investigaot# 75817

Kharkiv, 61075, Ukraine

Location

Site reference ID/Investigaot# 75813

Kiev, 01034, Ukraine

Location

Site Reference ID/Investigator# 75814

Kiev, 04112, Ukraine

Location

Site reference ID/Investigaot# 88056

Lviv, 79032, Ukraine

Location

Site reference ID/Investigaot# 75819

Mykolaiv, 54058, Ukraine

Location

Site reference ID/Investigaot# 77817

Odesa, 65000, Ukraine

Location

Site reference ID/Investigaot# 80193

Odesa, 65039, Ukraine

Location

Site reference ID/Investigator # 77813

Ternopil, 46020, Ukraine

Location

Site reference ID/Investigaot# 75818

Vinnytsia, 21009, Ukraine

Location

Site Reference ID/Investigator# 75822

Zaporizhzhia, 69071, Ukraine

Location

Site reference ID/Investigaot# 91973

Andijan, 170000, Uzbekistan

Location

Site reference ID/Investigaot# 91974

Andijan, 170100, Uzbekistan

Location

Site reference ID/Investigaot# 91987

Bukhara, 705000, Uzbekistan

Location

Site reference ID/Investigaot# 91975

Fergana, 150100, Uzbekistan

Location

Site reference ID/Investigaot# 91986

Samarkand, 140108, Uzbekistan

Location

Site reference ID/Investigaot# 100616

Tashkent, 100007, Uzbekistan

Location

Site reference ID/Investigaot# 91984

Tashkent, 100029, Uzbekistan

Location

Site reference ID/Investigaot# 91977

Tashkent, 100069, Uzbekistan

Location

Site reference ID/Investigaot# 91981

Tashkent, 100093, Uzbekistan

Location

Site reference ID/Investigaot# 91982

Tashkent, 100093, Uzbekistan

Location

Site reference ID/Investigaot# 92473

Tashkent, 100093, Uzbekistan

Location

Site reference ID/Investigaot# 91988

Tashkent, 100109, Uzbekistan

Location

Site reference ID/Investigaot# 92474

Tashkent, 100171, Uzbekistan

Location

Site reference ID/Investigaot# 91976

Tashkent, 100206, Uzbekistan

Location

Site reference ID/Investigaot# 91983

Tashkent, 100206, Uzbekistan

Location

Site reference ID/Investigaot# 91980

Urgench, 220100, Uzbekistan

Location

Site reference ID/Investigaot# 91985

Urgench, 220100, Uzbekistan

Location

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Follow up period was limited to 6 months of observation. Pregnancy incidence was not the aim of research, however, spontaneous pregnancies were observed in 56 (5.6%) patients following standard dosages of dydrogesterone for irregular cycle treatment.

Results Point of Contact

• Title: Senior Global Medical Director
• Organization: Abbott

Claire.Pexman-Fieth@abbott.com

+49 160 749 0615

Study Officials

• Claire Pexman-Fieth, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: October 22, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 22, 2015
• Results First Posted: October 30, 2015

Record last verified: 2015-11

Locations

UZ (17); KA (17); UA (13); RU (19)