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Trial record 84 of 107 for:    "21-hydroxylase deficiency"

Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome (MI-PCOS)

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ClinicalTrials.gov Identifier: NCT01788215
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Kathleen M. Hoeger, MD, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Polycystic Ovarian Syndrome (PCOS)
Irregular Menstrual Cycles
Androgen Excess
Interventions Drug: doxycycline
Other: Sugar Pill
Enrollment 10
Recruitment Details 13 women were recruited. 3 did not meet inclusion/esclusion criteria.
Pre-assignment Details  
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 5 5
12 Weeks of Doxycycline or Placebo 5 5
Completed 3 4
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             2             0
Arm/Group Title Doxycycline Sugar Pill Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
5
 100.0%
5
 100.0%
10
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
total serum testosterone  
Mean (Standard Deviation)
Unit of measure:  ng/dL
Number Analyzed 5 participants 5 participants 10 participants
50.6  (8.2) 49.6  (8.2) 50.1  (8.2)
free serum testosterone  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 5 participants 5 participants 10 participants
1.14  (0.57) 1.36  (0.39) 1.25  (0.48)
serum hormone binding globulin (SHBG)  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 5 participants 5 participants 10 participants
55.0  (13.2) 44.0  (13.5) 49.5  (13.4)
1.Primary Outcome
Title Total Serum Testosterone
Hide Description We will determine total serum testosterone levels in all participating subjects at week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
in the sugar pill arm one participant dropped out at week 12
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: ng/dL
61.8  (13.6) 41.6  (9.8)
2.Primary Outcome
Title Total Serum Testosterone
Hide Description We will determine total serum testosterone levels in all participating subjects at week 12.
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: ng/dL
49.4  (10.8) 43.0  (8.6)
3.Secondary Outcome
Title Serum Progesterone Levels in Blood
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Free Testosterone in Serum
Hide Description [Not Specified]
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: pg/mL
1.12  (0.39) 1.16  (0.25)
5.Secondary Outcome
Title Free Testosterone in Serum
Hide Description [Not Specified]
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
in the sugar till arm, one participant dropped out at week 12
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: pg/mL
1.76  (1.56) 1.08  (0.27)
6.Secondary Outcome
Title Serum Hormone Binding Globulin (SHBG)
Hide Description [Not Specified]
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: nmol/L
50.4  (12.4) 39.4  (10.9)
7.Secondary Outcome
Title Serum Hormone Binding Globulin (SHBG)
Hide Description [Not Specified]
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
in the sugar pill arm, one participant withdrew at week 12
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: nmol /L
44.8  (10.6) 36.2  (6.75)
8.Secondary Outcome
Title Total Number of Ovulations
Hide Description 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.
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
In the sugar pill arm, one participant withdrew at week 12.
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 5 4
Measure Type: Number
Unit of Measure: ovulations
12 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxycycline Sugar Pill
Hide Arm/Group Description

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

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

All-Cause Mortality
Doxycycline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Doxycycline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxycycline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
This study was underpowered due to reduced enrollment. Targeted enrollment was 40 and actual enrollment was 10.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathleen Hoeger MD MPH
Organization: University of Rochester
Phone: 585-275-7891
EMail: kathleen_hoeger@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Kathleen M. Hoeger, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT01788215     History of Changes
Other Study ID Numbers: RSRB 00034479
First Submitted: August 11, 2011
First Posted: February 11, 2013
Results First Submitted: October 23, 2015
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016