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The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline, on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian Syndrome (PCOS).
Polycystic ovarian syndrome (PCOS) is one of the leading causes of female infertility, affecting 5-10% of reproductive-age women . This heterogeneous disorder is characterized by anovulatory infertility, androgen excess, an increase in the ratio of LH to FSH, and morphologic polycystic changes to the ovaries. Obesity and insulin resistance are also metabolic factors associated with PCOS that further increase the morbidity in these patients. Inducing fertility in patients with PCOS can be a challenge, as it most often involves ovulation induction that can lead to ovarian enlargement, hyperstimulation, and multiple-birth pregnancies. This study is designed to determine novel effective strategies to promote normal cycling in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline | Active Comparator | 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. |
|
| Sugar Pill | Placebo Comparator | The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxycycline | Drug | 200mg/day in divided doses of 100mg twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Serum Testosterone | We will determine total serum testosterone levels in all participating subjects at week 24. | 24 weeks |
| Total Serum Testosterone | We will determine total serum testosterone levels in all participating subjects at week 12. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Progesterone Levels in Blood | 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. | 24 weeks |
| Free Testosterone in Serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Hoeger, MD, MPH | University of Rochester | Principal Investigator |
| Stephen Hammes, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester, Strong Fertility Center | Rochester | New York | 14623 | United States |
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13 women were recruited. 3 did not meet inclusion/esclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Serum Testosterone | We will determine total serum testosterone levels in all participating subjects at week 24. | in the sugar pill arm one participant dropped out at week 12 | Posted | Mean | Standard Deviation | ng/dL | 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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This study was underpowered due to reduced enrollment. Targeted enrollment was 40 and actual enrollment was 10.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Hoeger MD MPH | University of Rochester | 585-275-7891 | kathleen_hoeger@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D008599 | Menstruation Disturbances |
| D017588 | Hyperandrogenism |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Sugar Pill |
| Other |
1 pill twice a day |
|
|
| week 12 |
| Free Testosterone in Serum | week 24 |
| Serum Hormone Binding Globulin (SHBG) | week 12 |
| Serum Hormone Binding Globulin (SHBG) | week 24 |
| Total Number of Ovulations | 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. | week 24 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| total serum testosterone | Mean | Standard Deviation | ng/dL |
|
| free serum testosterone | Mean | Standard Deviation | pg/mL |
|
| serum hormone binding globulin (SHBG) | Mean | Standard Deviation | nmol/L |
|
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
|
|
| Secondary | Serum Progesterone Levels in Blood | 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. | 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. | Posted | 24 weeks |
|
|
| Primary | Total Serum Testosterone | We will determine total serum testosterone levels in all participating subjects at week 12. | Posted | Mean | Standard Deviation | ng/dL | week 12 |
|
|
|
| Secondary | Free Testosterone in Serum | Posted | Mean | Standard Deviation | pg/mL | week 12 |
|
|
|
| Secondary | Free Testosterone in Serum | in the sugar till arm, one participant dropped out at week 12 | Posted | Mean | Standard Deviation | pg/mL | week 24 |
|
|
|
| Secondary | Serum Hormone Binding Globulin (SHBG) | Posted | Mean | Standard Deviation | nmol/L | week 12 |
|
|
|
| Secondary | Serum Hormone Binding Globulin (SHBG) | in the sugar pill arm, one participant withdrew at week 12 | Posted | Mean | Standard Deviation | nmol /L | week 24 |
|
|
|
| Secondary | Total Number of Ovulations | 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. | In the sugar pill arm, one participant withdrew at week 12. | Posted | Number | ovulations | week 24 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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 | 0 | 5 | 0 | 5 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |