Polycystic Ovarian Syndrome (PCOS)Phase 3MI-PCOSNCT01788215
Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome
A Phase 3 study testing doxycycline and Sugar Pill in people with Polycystic Ovarian Syndrome (PCOS) and Irregular Menstrual Cycles, run by University of Rochester at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS), Irregular Menstrual Cycles, Androgen Excess
- What is being tested?
- doxycycline and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Sep 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 18 and 40 years of age.
- History of PCOS with < 8 periods the proceeding year
- Clinical or biochemical evidence of androgen excess
- BMI <40
- Willingness to sign consent for study including participation with collection of blood specimens
- Willingness to discontinue OCP for duration of study period up to 36 weeks
Who cannot join
- Pregnancy
- Hypersensitivity to doxycycline or tetracycline
- History of Cushing's syndrome
- History of hyperprolactinemia
- History of congenital adrenal hyperplasia
- Significant hepatic impairment, including serum AST or ALT >1.5 times upper limits of normal.
- Significant renal impairment, GFR <60 ml/min
- Current use of metformin, statins, glucocorticoids, spironolactone and/or anti-estrogens.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, Strong Fertility Center
Rochester, New York, 14623
About this study
Official title: The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome
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).
Read the detailed description
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.
- Being tested
- doxycycline, Sugar Pill
- Keywords
- Polycystic Ovarian Syndrome, Irregular Menstrual Cycles, Androgen Excess in Women
- Medical subject headings
- Polycystic Ovary Syndrome, Menstruation Disturbances, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycyclineDrug
200mg/day in divided doses of 100mg twice daily
Sugar PillOther
Also called Placebo
1 pill twice a day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: doxycycline |
| 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 Receives: Other: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Serum Testosterone
We will determine total serum testosterone levels in all participating subjects at week 24.
Measured: 24 weeks
Total Serum Testosterone
We will determine total serum testosterone levels in all participating subjects at week 12.
Measured: week 12
Secondary outcomes (6)
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.
Measured: 24 weeks
Free Testosterone in Serum
Measured: week 12
Free Testosterone in Serum
Measured: week 24
Serum Hormone Binding Globulin (SHBG)
Measured: week 12
Serum Hormone Binding Globulin (SHBG)
Measured: 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.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startNov 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen M. Hoeger, MD, University of Rochester
- Investigators
- Kathleen M Hoeger, MD, MPH, Principal investigator, University of RochesterStephen Hammes, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788215
- Sponsor's protocol ID
- RSRB 00034479
- Acronym
- MI-PCOS
- Status last verified
- Dec 2015
- First submitted
- 11 Aug 2011
- Last updated
- 13 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT01788215
- Acronym / sponsor ID
- MI-PCOS / RSRB 00034479
- Keywords
- Polycystic Ovarian Syndrome, Irregular Menstrual Cycles, Androgen Excess in Women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Posted 13 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: doxycyclineSubjects 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 | Other: Sugar PillThe administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women between 18 and 40 years of age.
- History of PCOS with < 8 periods the proceeding year
- Clinical or biochemical evidence of androgen excess
- BMI <40
- Willingness to sign consent for study including participation with collection of blood specimens
Key exclusion criteria (8 listed)
- Pregnancy
- Hypersensitivity to doxycycline or tetracycline
- History of Cushing's syndrome
- History of hyperprolactinemia
- History of congenital adrenal hyperplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxycycline200mg/day in divided doses of 100mg twice daily | Drug | Doxycycline |
| Sugar PillAlso: Placebo1 pill twice a day | Other | Sugar Pill |
Primary outcome
Total Serum Testosterone
Time frame: 24 weeks
We will determine total serum testosterone levels in all participating subjects at week 24.
Total Serum Testosterone
Time frame: week 12
We will determine total serum testosterone levels in all participating subjects at week 12.
6 secondary outcomes
Serum Progesterone Levels in Blood
Time frame: 24 weeks
Free Testosterone in Serum
Time frame: week 12
Free Testosterone in Serum
Time frame: week 24
Serum Hormone Binding Globulin (SHBG)
Time frame: week 12
Serum Hormone Binding Globulin (SHBG)
Time frame: week 24
Total Number of Ovulations
Time frame: week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Polycystic Ovarian Syndrome (PCOS)
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Hoeger, MD, MPH principal investigator
University of Rochester
Stephen Hammes, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing doxycycline and Sugar Pill in people with Polycystic Ovarian Syndrome (PCOS) and Irregular Menstrual Cycles, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Serum Testosterone (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.