Irregular Menstrual CycleNCT01711216

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

An observational study of Irregular Menstrual Cycle, run by Abbott at 66 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Irregular Menstrual Cycle
How many people: 999 participants
Where: 66 sitesin 4 countries
Study dates: Aug 2012to Aug 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
No healthy volunteers
Adult

Study population: women with irregular menstrual cycle due to progesterone deficiency

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

66 sites in 4 countries.

Country

City, postcode or hospital

66 sites in 4 countries

Russia19 sites

Site reference ID/Investigaotr# 76702
Irkutsk, 664003
Site reference ID/Investigator# 77753
Kazan', 420043
Site reference ID/Investigaotr# 76704
Kemerovo, 650029
Site reference ID/Investigator# 76701
Krasnodar, 350063 RF
Site reference ID/Investigaot# 88537
Moscow, 101000
Site reference ID/Investigaotr# 76708
Moscow, 117997
Site reference ID/Investigator# 76700
Moscow, 121243
Site reference ID/Investigator# 87013
Moscow, 127018
Site reference ID/Investigaot# 88535
Moscow, 127473
Site reference ID/Investigaot# 88514
Nizhny Novgorod, 603057
Site reference ID/Investigator# 83633
Novosibirsk
Site reference ID/Investigaot# 88536
Saint Petersburg, 194100
Site reference ID/Investigaotr# 76709
Saint Petersburg, 194100
Site reference ID/Investigator# 77754
Saint Petersburg, 195257
Site reference ID/Investigaotr# 76705
Tomsk, 634050
Site reference ID/Investigator# 77755
Tyumen, 625002
Site reference ID/Investigator# 82036
Volgograd, 400008
Site reference ID/Investigaot# 88513
Voronezh, 394036
Site reference ID/Investigator# 82035
Yekaterinburg, 620102

Other trials in Russia

Kazakhstan17 sites

Site reference ID/Investiagor# 82286
Aktobe, 030000
Site reference ID/Investiagor# 82287
Aktobe, 030000
Site reference ID/Investigator# 101795
Aktobe, 030000
Site reference ID/Investigator# 101799
Aktobe, 030000
Site reference ID/Investigator# 82279
Aktobe, 030000
Site reference ID/Investigator# 101798
Aktobe, 030019
Site reference ID/Investiagor# 82281
Almaty, 050000
Site reference ID/Investigator# 82293
Almaty, 050009
Site reference ID/Investigator# 101796
Astana, 010000
Site reference ID/Investigator# 101797
Astana, 010000
Site reference ID/Investigator# 82277
Astana, 010000
Site reference ID/Investigator# 82299
Astana, 010000
Site reference ID/Investigator# 82300
Astana, 010000
Site reference ID/Investigator# 82301
Astana, 10000
Site reference ID/Investiagor# 82282
Shymkent, 160000
Site reference ID/Investigator# 82275
Shymkent, 160000
Site reference ID/Investigator# 82288
Shymkent, 160000

Other trials in Kazakhstan

Uzbekistan17 sites

Site reference ID/Investigaot# 91973
Andijan, 170000
Site reference ID/Investigaot# 91974
Andijan, 170100
Site reference ID/Investigaot# 91987
Bukhara, 705000
Site reference ID/Investigaot# 91975
Fergana, 150100
Site reference ID/Investigaot# 91986
Samarkand, 140108
Site reference ID/Investigaot# 100616
Tashkent, 100007
Site reference ID/Investigaot# 91984
Tashkent, 100029
Site reference ID/Investigaot# 91977
Tashkent, 100069
Site reference ID/Investigaot# 91981
Tashkent, 100093
Site reference ID/Investigaot# 91982
Tashkent, 100093
Site reference ID/Investigaot# 92473
Tashkent, 100093
Site reference ID/Investigaot# 91988
Tashkent, 100109
Site reference ID/Investigaot# 92474
Tashkent, 100171
Site reference ID/Investigaot# 91976
Tashkent, 100206
Site reference ID/Investigaot# 91983
Tashkent, 100206
Site reference ID/Investigaot# 91980
Urgench, 220100
Site reference ID/Investigaot# 91985
Urgench, 220100

Other trials in Uzbekistan

Ukraine13 sites

Site reference ID/Investigaot# 75815
Dnipropetrovsk, 49000
Site Reference ID/Investigator# 75816
Ivano-Frankivsk, 76000
Site reference #/Investigator ID 77816
Kharkiv, 61050
Site reference ID/Investigaot# 75817
Kharkiv, 61075
Site reference ID/Investigaot# 75813
Kiev, 01034
Site Reference ID/Investigator# 75814
Kiev, 04112
Site reference ID/Investigaot# 88056
Lviv, 79032
Site reference ID/Investigaot# 75819
Mykolaiv, 54058
Site reference ID/Investigaot# 77817
Odesa, 65000
Site reference ID/Investigaot# 80193
Odesa, 65039
Site reference ID/Investigator # 77813
Ternopil, 46020
Site reference ID/Investigaot# 75818
Vinnytsia, 21009
Site Reference ID/Investigator# 75822
Zaporizhzhya, 69071

Other trials in Ukraine

About this study

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

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.

Read the 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.

Conditions: Irregular Menstrual Cycle
Keywords: Dydrogesterone, Irregular Menstrual Cycle, Progestins
Medical subject headings: Menstruation Disturbances

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01711216
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (16)

Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period
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
Measured: Up to 6 months
Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea
Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated
Measured: From 1 month to 6 months
Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea
Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated
Measured: From 1 month to 6 months
Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea
Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days
Measured: From 1 month to 6 months
Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea
Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days
Measured: From 1 month to 6 months
Change of Pain Intensity During Menstruation From Baseline to End of Treatment
Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain
Measured: From 1 month to 6 months
Change of Intensity of Anxiety From Baseline to the End of Treatment
Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety
Measured: From 1 month to 6 months
Patient Satisfaction With the Treatment
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.
Measured: Up to 6 months
Overall Clinical Response on Treatment Assessed by Physician
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.
Measured: 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
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
Measured: 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
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
Measured: Up to 12 months
Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea
Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days
Measured: From 1 month to 12 months
Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea
Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days
Measured: From 1 month to 12 months
Change of Pain Intensity During Menstruation
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
Measured: From 1 month to 12 months
Change of Intensity of Anxiety
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
Measured: From 1 month to 12 months
Time to Relapse
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.
Measured: Up to 6 months or longer after ended treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Aug 2014

First posted22 Oct 2012 (estimated)
Study startAug 2012
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Irregular Menstrual CycleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 999 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01711216
Sponsor's protocol ID: P13-688
Status last verified: Nov 2015
First submitted: 22 Aug 2012
Last updated: 22 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Irregular Menstrual Cycle trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01711216
Acronym / sponsor ID: P13-688
Conditions: Irregular Menstrual Cycle
Keywords: Dydrogesterone, Irregular Menstrual Cycle, Progestins
Study type: Observational
Recruitment status: Completed
Enrolment: 999 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 22 Oct 2012 (estimated)
Results: Posted 30 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

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

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: women with irregular menstrual cycle due to progesterone deficiency

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

16 secondary outcomes

Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period
Time frame: 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
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
Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea
Time frame: 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
Change of Pain Intensity During Menstruation From Baseline to End of Treatment
Time frame: 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
Patient Satisfaction With the Treatment
Time frame: Up to 6 months
Overall Clinical Response on Treatment Assessed by Physician
Time frame: 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
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
Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea
Time frame: 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
Change of Pain Intensity During Menstruation
Time frame: From 1 month to 12 months
Change of Intensity of Anxiety
Time frame: From 1 month to 12 months
Time to Relapse
Time frame: Up to 6 months or longer after ended treatment

Results and safety

Results posted to the registry on 30 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Women Received Dydrogesterone for Irregular Menstrual Cycle	999	782

Primary outcome: Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)

Time frame: up to 6 months. Number. Unit: participants

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n = 860
1 therapy cycle	1
2 therapy cycles	4
3 therapy cycles	269
4 therapy cycles	66
5 therapy cycles	53
6 therapy cycles	467

Population analysed: Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.

Primary outcome: Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)

Time frame: up to 6 months. Number. Unit: participants

Measure	Women Received Dydrogesterone for Irregular Menstrual Cycle n = 860
0 regular cycles	6
1 regular cycle	32
2 regular cycles	31
3 regular cycles	29
4 regular cycles	26
5 regular cycles	56
6 regular cycles	545
7 regular cycles	84

Women Received Dydrogesterone for Irregular Menstrual Cycle: p = 0.3181, Mantel Haenszel

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety was monitored by recording of serious adverse events (SAEs) and pregnancies and spontaneously reported adverse events (AEs) from signed informed consent up to 30 days after the final dose of dydrogesterone.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Women Received Dydrogesterone for Irregular Menstrual Cycle	2 of 986 (0.2%)	14 of 986 (1.4%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claire Pexman-Fieth, MD study director

Abbott

66 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Irregular Menstrual Cycle, run by Abbott at 66 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Russia, Kazakhstan, Uzbekistan, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01711216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.