Trial Outcomes & Findings for A Study of Continuous Oral Contraceptives and Doxycycline (NCT NCT00480532)
NCT ID: NCT00480532
Last Updated: 2014-10-22
Results Overview
number of days of bleeding and spotting, self reported on calendar
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
The outcome was also assessed for day 1 to 84
Results posted on
2014-10-22
Participant Flow
Recruitment at Oregon Health and Science University (OHSU) and University of Hawaii (UH
Participant milestones
| Measure |
Placebo (Treatment)
Placebo (for treatment portion of the study)
|
Doxy (7 Day Treatment Arm)
Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
|
Placebo (Prevention)
Placebo for prevention portion of the study
|
Subantibmicrobial Dose Doxy
Doxycycline 40mg (sustained release) once daily for 84 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
33
|
32
|
|
Overall Study
COMPLETED
|
31
|
29
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
1
|
Reasons for withdrawal
| Measure |
Placebo (Treatment)
Placebo (for treatment portion of the study)
|
Doxy (7 Day Treatment Arm)
Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
|
Placebo (Prevention)
Placebo for prevention portion of the study
|
Subantibmicrobial Dose Doxy
Doxycycline 40mg (sustained release) once daily for 84 days
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Continuous Oral Contraceptives and Doxycycline
Baseline characteristics by cohort
| Measure |
Placebo (Treatment)
n=33 Participants
Placebo (for treatment portion of the study)
|
Doxy (7 Day Treatment Arm)
n=33 Participants
Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
|
Placebo (Prevention)
n=33 Participants
Placebo for prevention portion of the study
|
Subantibmicrobial Dose Doxy
n=32 Participants
Doxycycline 40mg (sustained release) once daily for 84 days
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
27.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
28.0 years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
33 participants
n=5 Participants
|
32 participants
n=4 Participants
|
131 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: The outcome was also assessed for day 1 to 84Population: All participants analyzed in the groups to which they were randomized except for 1 subject in prevention placebo group who was erroneously enrolled although she did not meet enrollment entry criteria
number of days of bleeding and spotting, self reported on calendar
Outcome measures
| Measure |
Placebo (Treatment)
n=33 Participants
Placebo (for treatment portion of the study)
|
Doxy (7 Day Treatment Arm)
n=33 Participants
Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
|
Placebo (Prevention)
n=32 Participants
Placebo for prevention portion of the study
|
Subantibmicrobial Dose Doxy
n=32 Participants
Doxycycline 40mg (sustained release) once daily for 84 days
|
|---|---|---|---|---|
|
Differences in Bleeding Patterns Between Study Groups.
|
26.72 days
Standard Error 4.89
|
31.86 days
Standard Error 5.08
|
25.69 days
Standard Error 3.24
|
18.84 days
Standard Error 3.30
|
SECONDARY outcome
Timeframe: Assessed on day 112 of the study (the end of the study period). This outcome does not represent a change from baseline. It was assessed at the end of the study period.measured using 100 mm visual analog scale. anchors of "not at all satisfied" (0mm) "extremely satisfied" (100mm)
Outcome measures
| Measure |
Placebo (Treatment)
n=33 Participants
Placebo (for treatment portion of the study)
|
Doxy (7 Day Treatment Arm)
n=33 Participants
Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
|
Placebo (Prevention)
n=32 Participants
Placebo for prevention portion of the study
|
Subantibmicrobial Dose Doxy
n=32 Participants
Doxycycline 40mg (sustained release) once daily for 84 days
|
|---|---|---|---|---|
|
Subject Satisfaction.
|
63.9 mm
Standard Deviation 41.1
|
64.2 mm
Standard Deviation 33.0
|
72.0 mm
Standard Deviation 30.9
|
67.0 mm
Standard Deviation 35.3
|
SECONDARY outcome
Timeframe: Assessed on day 112 of the study (the end of the study period). The outcome reflects the number of subjects who did not miss pills during the entire 112 day study. It does not represent a change from baseline.measured by self report of pill intake on daily diary (yes/no), and reported as percentage with no missed pills over entire study
Outcome measures
| Measure |
Placebo (Treatment)
n=33 Participants
Placebo (for treatment portion of the study)
|
Doxy (7 Day Treatment Arm)
n=33 Participants
Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
|
Placebo (Prevention)
n=32 Participants
Placebo for prevention portion of the study
|
Subantibmicrobial Dose Doxy
n=32 Participants
Doxycycline 40mg (sustained release) once daily for 84 days
|
|---|---|---|---|---|
|
Subject Compliance
|
25 number of participants with no missed pi
|
21 number of participants with no missed pi
|
19 number of participants with no missed pi
|
20 number of participants with no missed pi
|
Adverse Events
Placebo (Treatment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Doxy (7 Day Treatment Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Prevention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subantibmicrobial Dose Doxy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place