Trial Outcomes & Findings for Impact of Combined Hormonal Contraceptives on UPA (NCT NCT02577601)
NCT ID: NCT02577601
Last Updated: 2019-11-08
Results Overview
Following dosing with UPA, subjects underwent daily visits with ultrasound monitoring until evidence of follicle rupture (complete disappearance or \>50% reduction of the mean size of the leading follicle).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
within 5 days of taking the study drug
Results posted on
2019-11-08
Participant Flow
Participant milestones
| Measure |
Treatment Cycles
UPA only: During the first treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10). Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. Cycle 1: Ulipristal Acetate
UPA+COC: During the second treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10) and then 2 days later start birth control pills. Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. Cycle 3: Ulipristal Acetate and Levonorgestrel (LNG)/Ethinyl estradiol birth control pill
|
|---|---|
|
UPA Only (1 Month)
STARTED
|
36
|
|
UPA Only (1 Month)
COMPLETED
|
36
|
|
UPA Only (1 Month)
NOT COMPLETED
|
0
|
|
Washout (1 Month)
STARTED
|
33
|
|
Washout (1 Month)
COMPLETED
|
33
|
|
Washout (1 Month)
NOT COMPLETED
|
0
|
|
UPA+COC (1 Month)
STARTED
|
33
|
|
UPA+COC (1 Month)
COMPLETED
|
33
|
|
UPA+COC (1 Month)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Combined Hormonal Contraceptives on UPA
Baseline characteristics by cohort
| Measure |
All Cycles
n=36 Participants
During the first treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10). Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. Cycle 1: Ulipristal Acetate
The month following this first treatment month (washout-cycle),there will be no study visits during this menstrual cycle but there will be contact with study staff (1 or 2 times) by telephone or email to discuss any health changes that are experiencing.
During the second treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10) and then 2 days later start birth control pills. Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. Cycle 3: Ulipristal Acetate and Levonorgestrel (LNG)/Ethinyl estradiol birth control pill
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 3.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: within 5 days of taking the study drugFollowing dosing with UPA, subjects underwent daily visits with ultrasound monitoring until evidence of follicle rupture (complete disappearance or \>50% reduction of the mean size of the leading follicle).
Outcome measures
| Measure |
UPA Only
n=33 Participants
During the first treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10). Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier.
Ulipristal Acetate
|
UPA + COC
n=33 Participants
During the second treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10) and then 2 days later start birth control pills. Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier.
Ulipristal Acetate
Levonorgestrel (LNG)/Ethinyl estradiol birth control pill
|
|---|---|---|
|
Number of Participants With Follicle Rupture
|
1 Participants
|
9 Participants
|
Adverse Events
UPA Only
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Washout Cycle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UPA + COC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
UPA Only
n=36 participants at risk
During the first treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10). Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier.
Ulipristal Acetate
|
Washout Cycle
n=33 participants at risk
The month following this first treatment month (washout-cycle),there will be no study visits during this menstrual cycle but there will be contact with study staff (1 or 2 times) by telephone or email to discuss any health changes that are experiencing.
|
UPA + COC
n=33 participants at risk
During the second treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10) and then 2 days later start birth control pills. Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier.
Ulipristal Acetate
Levonorgestrel (LNG)/Ethinyl estradiol birth control pill
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Malar rash
|
2.8%
1/36 • Number of events 1 • up to 3 months
|
0.00%
0/33 • up to 3 months
|
0.00%
0/33 • up to 3 months
|
Additional Information
Ob/Gyn Regulatory Specialist
Oregon Health & Science University
Phone: 503-494-0757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place