Trial Outcomes & Findings for Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive (NCT NCT01963403)

NCT ID: NCT01963403

Last Updated: 2017-05-12

Results Overview

Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 26 participants
• Primary outcome timeframe: Bleeding improvement will be evaluated during first cycle of study treatment (28 days)
• Results posted on: 2017-05-12

Participant Flow

Participant milestones

Measure	EE 30mcg/LNG 150mcg combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)	Placebo Placebo Placebo: 1 pill per day; daily during study participation (up to 84 days)
Overall Study STARTED	13	13
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	EE 30mcg/LNG 150mcg combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)	Placebo Placebo Placebo: 1 pill per day; daily during study participation (up to 84 days)
Overall Study Lost to Follow-up	2	3
Overall Study Implant removal	0	1

Baseline Characteristics

Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive

Baseline characteristics by cohort

Measure	EE 30mcg/LNG 150mcg n=13 Participants combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)	Placebo n=13 Participants Placebo Placebo: 1 pill per day; daily during study participation (up to 84 days)	Total n=26 Participants Total of all reporting groups
Age, Continuous	25.4 years STANDARD_DEVIATION 3.8 • n=5 Participants	25.8 years STANDARD_DEVIATION 5.0 • n=7 Participants	25.6 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants
Primary reason for implant Contraception	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Primary reason for implant Bleeding Problem	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Primary reason for implant Dysmenorrhea	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Duration of implant use	343 days n=5 Participants	109 days n=7 Participants	144.5 days n=5 Participants
intervention requested before enrollment implant removal	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
intervention requested before enrollment Hormonal treatment	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
intervention requested before enrollment 'Some treatment'	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Bleeding improvement will be evaluated during first cycle of study treatment (28 days)

Population: 1 person in each group LTFU at one month, which was the primary outcome

Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.

Outcome measures

Measure	EE 30mcg/LNG 150mcg n=12 Participants combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)	Placebo n=12 Participants Placebo Placebo: 1 pill per day; daily during study participation (up to 84 days)
Number of Participants With Bleeding Improvement Significant improvement	11 Participants	5 Participants
Number of Participants With Bleeding Improvement Slight improvement	1 Participants	3 Participants
Number of Participants With Bleeding Improvement No change	0 Participants	2 Participants
Number of Participants With Bleeding Improvement Slightly worse	0 Participants	2 Participants
Number of Participants With Bleeding Improvement Significantly worse	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant

Population: Outcomes at one month; 1 person LTFU at one month in each group

Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.

Outcome measures

Measure	EE 30mcg/LNG 150mcg n=12 Participants combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)	Placebo n=12 Participants Placebo Placebo: 1 pill per day; daily during study participation (up to 84 days)
Number of Participants With Adverse Events Headache	5 Participants	4 Participants
Number of Participants With Adverse Events Nausea/vomiting	1 Participants	1 Participants
Number of Participants With Adverse Events Cramping	0 Participants	2 Participants
Number of Participants With Adverse Events Mood change	0 Participants	1 Participants
Number of Participants With Adverse Events None of above	6 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months

Population: one month evaluation; 1 subject LTFU at one month in each group

Treatment success will be measured by desire to continue treatment because the initial treatment made the bleeding better.

Partial failure of the study treatment will be measured by the desire to continue treatment because the initial treatment did not work

Complete failure of treatment will be measured by the desire to:

• discontinue treatment because it did not work; no further treatment requested
• ETG implant removal
• Desire to use non-study treatment

Outcome measures

Measure	EE 30mcg/LNG 150mcg n=12 Participants combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)	Placebo n=12 Participants Placebo Placebo: 1 pill per day; daily during study participation (up to 84 days)
Number of Participants withTreatment Success or Failure Continued assigned treatment	8 Participants	5 Participants
Number of Participants withTreatment Success or Failure Desired COC prescription	4 Participants	4 Participants
Number of Participants withTreatment Success or Failure Desired no treatment	0 Participants	2 Participants
Number of Participants withTreatment Success or Failure Implant removal	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months

• Bleeding improvement in women who received placebo but opted for open-label treatment after first cycle
• Bleeding improvement over the 84 days of study participation
• Bleeding patterns in placebo vs. combined oral contraceptive users

Outcome measures

Measure	EE 30mcg/LNG 150mcg n=16 Participants combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)	Placebo n=5 Participants Placebo Placebo: 1 pill per day; daily during study participation (up to 84 days)
Bleeding Patterns and Number of Participants With Bleeding Improvement Bleeding improvement	12 Participants	5 Participants
Bleeding Patterns and Number of Participants With Bleeding Improvement No bleeding improvement	4 Participants	0 Participants

Adverse Events

EE 30mcg/LNG 150mcg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	EE 30mcg/LNG 150mcg n=12 participants at risk Combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)	Placebo n=12 participants at risk Placebo: 1 pill per day; daily during study participation (up to 84 days)
General disorders Headache	41.7% 5/12 • Number of events 5 • Up to 84 days on either medication or placebo. Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.	33.3% 4/12 • Number of events 4 • Up to 84 days on either medication or placebo. Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.
Gastrointestinal disorders Nausea/vomiting	8.3% 1/12 • Number of events 1 • Up to 84 days on either medication or placebo. Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.	8.3% 1/12 • Number of events 1 • Up to 84 days on either medication or placebo. Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.
General disorders Cramping	0.00% 0/12 • Up to 84 days on either medication or placebo. Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.	16.7% 2/12 • Number of events 2 • Up to 84 days on either medication or placebo. Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.
General disorders Mood change	0.00% 0/12 • Up to 84 days on either medication or placebo. Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.	8.3% 1/12 • Number of events 1 • Up to 84 days on either medication or placebo. Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.

Additional Information

Dr. Mitchell Creinin

UC Davis

Phone: 916-734-6670

Email: mdcreinin@ucdavis.edu

Results disclosure agreements

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