Trial Outcomes & Findings for Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study (NCT NCT01525563)

NCT ID: NCT01525563

Last Updated: 2014-12-29

Results Overview

Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.

• Recruitment status: COMPLETED
• Target enrollment: 1000 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2014-12-29

Participant Flow

Participant milestones

Measure	Subjects With Irregular Menstrual Cycle Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
Overall Study STARTED	1000
Overall Study End of Treatment	910
Overall Study 3 Months Follow-up	838
Overall Study COMPLETED	788
Overall Study NOT COMPLETED	212

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study

Baseline characteristics by cohort

Measure	Subjects With Irregular Menstrual Cycle n=1000 Participants Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
Age, Customized Age	29.2 years STANDARD_DEVIATION 7.41 • n=5 Participants
Sex/Gender, Customized Female	1000 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intent-to-Treat Population

Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.

Outcome measures

Measure	Subjects With Irregular Menstrual Cycle n=910 Participants All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
Percentage of Patients Reporting a Regular Cycle	96.7 percentage of participants Interval 95.5 to 97.9

SECONDARY outcome

Timeframe: 6 months

Population: All patients were assessed for overall reduction in cycle duration (910).

The evolution of cycle duration from baseline to EOT was assessed by mean cycle duration (in days) at baseline, separately in polymenorrhea and oligomenorrhea groups, and at the EOT. The patients were included in polymenorrhea group in case the cycle duration at baseline was less than 21 days and in oligomenorrhea group in case the cycle duration at baseline was greater than 35 days.

Outcome measures

Measure	Subjects With Irregular Menstrual Cycle n=910 Participants All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT) Cycle duration at baseline	44.73 Days Standard Deviation 25.38
Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT) Cycle duration at EOT	28.59 Days Standard Deviation 7.61
Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT) change from baseline to EOT	-16.14 Days Standard Deviation 24.04

SECONDARY outcome

Timeframe: 6 months

Population: The amount of menstrual bleeding (based on no. of pads used per day) was analyzed for all subjects completing EOT and change was noted from baseline to EOT

Assessment of average number of pads changed per day at baseline and at the end of treatment (EOT).

Outcome measures

Measure	Subjects With Irregular Menstrual Cycle n=910 Participants All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
Amount of Menstrual Bleeding From Baseline to End of Treatment baseline amount of bleeding	3.08 pads/day Standard Deviation 1.26
Amount of Menstrual Bleeding From Baseline to End of Treatment EOT amount of bleeding	2.63 pads/day Standard Deviation 0.89
Amount of Menstrual Bleeding From Baseline to End of Treatment Change from baseline to EOT	-0.45 pads/day Standard Deviation 1.20

SECONDARY outcome

Timeframe: 6 months

Population: The scores for pain during menstruation were recorded on 11-point Likert scale on baseline for all enrolled subjects and end of treatment where 0 means no pain, and 10 means worst pain.

The scores for pain during menstruation were recorded on 11-point Likert scale on baseline and end of treatment where 0 means no pain, and 10 means worst pain.

Outcome measures

Measure	Subjects With Irregular Menstrual Cycle n=910 Participants All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
Evolution of Pain During Menstruation From Baseline to End of Treatment No. of participants at Baseline (Scale 0-No Pain)	139 participants
Evolution of Pain During Menstruation From Baseline to End of Treatment No. of participants EOT (Scale 0-No Pain)	200 participants
Evolution of Pain During Menstruation From Baseline to End of Treatment No. of participants Baseline (Scale 10-Worst Pain)	5 participants
Evolution of Pain During Menstruation From Baseline to End of Treatment No. of participants EOT (Scale 10-Worst Pain)	0 participants

SECONDARY outcome

Timeframe: 6 months

Population: Overall at the EOT, of 910 patients population the overall satisfaction was assessed

The overall patient satisfaction was recorded on a 5 point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied).

Outcome measures

Measure	Subjects With Irregular Menstrual Cycle n=910 Participants All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
Overall Patient Satisfaction EOT - Patient satisfaction (satisfied - 4)	532 participants
Overall Patient Satisfaction EOT - Patient satisfaction (very satisfied - 5)	282 participants

SECONDARY outcome

Timeframe: 6 months

Population: To observe the evolution of duration of menstrual bleeding from baseline (all enrolled) to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment (EOT).

To observe the evolution of duration of menstrual bleeding from baseline to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment.

Outcome measures

Measure	Subjects With Irregular Menstrual Cycle n=910 Participants All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment duration of menstrual bleeding at baseline (days)	4.99 Days Standard Deviation 3.15
Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment duration of menstrual bleeding at EOT (days)	4.29 Days Standard Deviation 1.38

SECONDARY outcome

Timeframe: 6 months

Population: Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.

Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.

Outcome measures

Measure	Subjects With Irregular Menstrual Cycle n=910 Participants All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
Overall Clinical Response Overall Clinical Response EOT (Normal, not ill)	851 participants
Overall Clinical Response Overall Clinical Response EOT(Most extremely ill)	0 participants

Adverse Events

Subjects With Irregular Menstrual Cycle

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Subjects With Irregular Menstrual Cycle n=1000 participants at risk Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
Infections and infestations Appendicitis	0.10% 1/1000 • Number of events 1 • 6 months treatment duration + 6 months follow up period (15 months) The safety analysis set included all enrolled patients who satisfied all inclusion and exclusion criteria

Other adverse events

Measure	Subjects With Irregular Menstrual Cycle n=1000 participants at risk Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
Immune system disorders Hypersensitivity	0.10% 1/1000 • Number of events 1 • 6 months treatment duration + 6 months follow up period (15 months) The safety analysis set included all enrolled patients who satisfied all inclusion and exclusion criteria
Reproductive system and breast disorders Adenomyosis	0.10% 1/1000 • Number of events 1 • 6 months treatment duration + 6 months follow up period (15 months) The safety analysis set included all enrolled patients who satisfied all inclusion and exclusion criteria
Reproductive system and breast disorders Menstruation Irregular	0.10% 1/1000 • Number of events 1 • 6 months treatment duration + 6 months follow up period (15 months) The safety analysis set included all enrolled patients who satisfied all inclusion and exclusion criteria

Additional Information

Associate Director Clinical Services

Abbott

Email: taco.baardman@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER