Trial Outcomes & Findings for Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome (NCT NCT01788215)
NCT ID: NCT01788215
Last Updated: 2016-01-13
Results Overview
We will determine total serum testosterone levels in all participating subjects at week 24.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
24 weeks
Results posted on
2016-01-13
Participant Flow
13 women were recruited. 3 did not meet inclusion/esclusion criteria.
Participant milestones
| Measure |
Doxycycline
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
12 Weeks of Doxycycline or Placebo
|
5
|
5
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Doxycycline
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome
Baseline characteristics by cohort
| Measure |
Doxycycline
n=5 Participants
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
n=5 Participants
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
Total
n=10 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
total serum testosterone
|
50.6 ng/dL
STANDARD_DEVIATION 8.2 • n=5 Participants
|
49.6 ng/dL
STANDARD_DEVIATION 8.2 • n=7 Participants
|
50.1 ng/dL
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
free serum testosterone
|
1.14 pg/mL
STANDARD_DEVIATION 0.57 • n=5 Participants
|
1.36 pg/mL
STANDARD_DEVIATION 0.39 • n=7 Participants
|
1.25 pg/mL
STANDARD_DEVIATION 0.48 • n=5 Participants
|
|
serum hormone binding globulin (SHBG)
|
55.0 nmol/L
STANDARD_DEVIATION 13.2 • n=5 Participants
|
44.0 nmol/L
STANDARD_DEVIATION 13.5 • n=7 Participants
|
49.5 nmol/L
STANDARD_DEVIATION 13.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: in the sugar pill arm one participant dropped out at week 12
We will determine total serum testosterone levels in all participating subjects at week 24.
Outcome measures
| Measure |
Doxycycline
n=5 Participants
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
n=4 Participants
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
|---|---|---|
|
Total Serum Testosterone
|
61.8 ng/dL
Standard Deviation 13.6
|
41.6 ng/dL
Standard Deviation 9.8
|
PRIMARY outcome
Timeframe: week 12We will determine total serum testosterone levels in all participating subjects at week 12.
Outcome measures
| Measure |
Doxycycline
n=5 Participants
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
n=5 Participants
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
|---|---|---|
|
Total Serum Testosterone
|
49.4 ng/dL
Standard Deviation 10.8
|
43.0 ng/dL
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: This measurement was not completed, because the number of ovulations was measured in its place and better indicates the effect of the treatment. See outcome measure number 8.
Serum progesterone levels will be obtained on a weekly basis to assess ovulation. We will then perform statistical analysis on this data to determine the effectiveness of doxycycline in this study population.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 12Outcome measures
| Measure |
Doxycycline
n=5 Participants
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
n=5 Participants
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
|---|---|---|
|
Free Testosterone in Serum
|
1.12 pg/mL
Standard Deviation 0.39
|
1.16 pg/mL
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: week 24Population: in the sugar till arm, one participant dropped out at week 12
Outcome measures
| Measure |
Doxycycline
n=5 Participants
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
n=4 Participants
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
|---|---|---|
|
Free Testosterone in Serum
|
1.76 pg/mL
Standard Deviation 1.56
|
1.08 pg/mL
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: week 12Outcome measures
| Measure |
Doxycycline
n=5 Participants
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
n=5 Participants
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
|---|---|---|
|
Serum Hormone Binding Globulin (SHBG)
|
50.4 nmol/L
Standard Deviation 12.4
|
39.4 nmol/L
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: week 24Population: in the sugar pill arm, one participant withdrew at week 12
Outcome measures
| Measure |
Doxycycline
n=5 Participants
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
n=4 Participants
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
|---|---|---|
|
Serum Hormone Binding Globulin (SHBG)
|
44.8 nmol /L
Standard Deviation 10.6
|
36.2 nmol /L
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: week 24Population: In the sugar pill arm, one participant withdrew at week 12.
The total number of ovulations per group. Ovulation was defined as elevation of serum progesterone and or urinary pregnanediol glucuronide followed by documented menstrual bleeding within 2 weeks of elevation.
Outcome measures
| Measure |
Doxycycline
n=5 Participants
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
doxycycline: 200mg/day in divided doses of 100mg twice daily
|
Sugar Pill
n=4 Participants
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Sugar Pill: 1 pill twice a day
|
|---|---|---|
|
Total Number of Ovulations
|
12 ovulations
|
7 ovulations
|
Adverse Events
Doxycycline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill
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