Polycystic Ovarian SyndromeNCT01070160
Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)
An observational study of Polycystic Ovarian Syndrome, run by Yale University at 1 site in United States.
Trial summary
The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with Metformin. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome
- What is being tested?
- Endometrin (progesterone 100mg vaginal inserts) and Metformin
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Women will be recruited from the multi-physician Yale Reproductive Endocrinology clinical practice and Yale Fertility Center. Metformin is a routinely employed therapeutic strategy utilized for managing PCOS by practitioners at YFC. Almost 1/3 of the patients with PCOS are not interested in pursuing fertility in the immediate future and it is these patients who will be offered participation in the trial.
Who may be able to join
- Premenopausal between 18-42 years of age
- Diagnosed with PCOS as defined by chronic oligo- or amenorrhea (8 menstrual periods annually); biochemical hyperandrogenemia (elevated total or free testosterone) and /or clinical hyperandrogenism (excessive facial hair \&/or acne); exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone <200 ng/dl).
- Acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis) performed within the past 6 months
- Able to provide signed informed consent
- Able to comply with study requirements
- Willing to delay the start of clinically prescribed metformin treatment
Who cannot join
- Known diabetics or those with clinically significant and known pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer)
- Current use of hormonal contraceptives
- Seeking pregnancy; use of fertility drugs within 6 months of study
- Current or recent (within 3 months) use of metformin
- Ingestion of any investigational drug within two months prior to study onset
- Evidence of endometrial hyperplasia or cancer upon baseline EMBx
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital Women's Center
New Haven, Connecticut, 06520-8063
About this study
The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with Metformin. We propose that improving insulin sensitivity with use of Metformin in women diagnosed with PCOS has facilitatory influences on the uterine endometrium.
Read the detailed description
Endometrial assessments are proposed following three month and then nine month treatment with metformin; expression of specified markers at respective time points will be compared to baseline.
Visit 1: Screening
- Signed informed consent
- Comprehensive history intake
- Physical exam: Vital signs, height, weight, waist circumferences, waist : hip ratio
- Urine pregnancy test
- Subjects provided with a 10 day supply of vaginal progesterone and EMBx will be scheduled between days 6-8 of progesterone use.
Visit 2: Baseline
- Urine pregnancy test
- Endometrium thickness will be measured via transvaginal ultrasound
- EMBx: sample of endometrial tissue will be sent for histopathology to rule out endometrial hyperplasia or cancer
- 20cc blood
- Metformin prescription and dispensing will be as per clinical care.
- Women will be advised to use barrier method of contraception (ie; condoms, contraceptive jellies or foam, sponge, diaphragm, or cervical cap) for the duration of the study.
Visits 3 and 5 (Weeks 8-10 and 30-34, respectively)
- Urine pregnancy test
- A 10 day course of vaginal progesterone to allow scheduling of EMBx's time points specified under visit 1
Visits 4 and 6 (Weeks 12 ± 1 week and 36 ± 1 week respectively)
- The procedure specified for baseline (Visit 2) will be repeated.
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- Endometrin (progesterone 100mg vaginal inserts), Metformin
- Keywords
- Polycystic Ovarian Syndrome (PCOS), Metformin, Endometrin
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrin (progesterone 100mg vaginal inserts)Drug
once a day, 6-8 days as specified (prior to each EMBx)
MetforminDrug
per clinical care guidelines
| Study group | Role | What they receive |
|---|---|---|
| A | Women with PCOS initiating Metformin and exposure to vaginal progesterone for 6-8 days prior ro Endometrium Biopsy Receives: Drug: Endometrin (progesterone 100mg vaginal inserts); Drug: Metformin | |
| B | Women with PCOS not planning initiating Metformin and exposure to vaginal progesterone for 6-8 days prior to Endometrium Biopsy Receives: Drug: Endometrin (progesterone 100mg vaginal inserts) | |
| Women with PCOS who previously initiated metformin | Women with PCOS who initiated metformin at least 3 months prior to enrollment who have completed a 6-10 day course of progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy
Measured: baseline
It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy
Measured: 3 months
It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy
Measured: 9 months
Secondary outcomes (2)
blood draw (20mL)
Measured: on day of EMBx
A combination of quantitative real time PCR, immunohistochemistry, and Western Blot techniques will be utilized for studying endometrial markers of receptivity in the endometrial tissue
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJun 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lubna Pal, MBBS MRCOG MSc, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070160
- Sponsor's protocol ID
- 0905005203
- Other IDs
- U54HD052668-02
- Status last verified
- Jun 2014
- First submitted
- 16 Feb 2010
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT01070160
- Acronym / sponsor ID
- 0905005203
- Conditions
- Polycystic Ovarian Syndrome
- Keywords
- Polycystic Ovarian Syndrome (PCOS), Metformin, Endometrin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with Metformin. We propose that improving insulin sensitivity with use of Metformin in women diagnosed with PCOS has facilitatory influences on the uterine endometrium.
Detailed description
Endometrial assessments are proposed following three month and then nine month treatment with metformin; expression of specified markers at respective time points will be compared to baseline.
Visit 1: Screening
- Signed informed consent
- Comprehensive history intake
- Physical exam: Vital signs, height, weight, waist circumferences, waist : hip ratio
- Urine pregnancy test
- Subjects provided with a 10 day supply of vaginal progesterone and EMBx will be scheduled between days 6-8 of progesterone use.
Visit 2: Baseline
- Urine pregnancy test
- Endometrium thickness will be measured via transvaginal ultrasound
- EMBx: sample of endometrial tissue will be sent for histopathology to rule out endometrial hyperplasia or cancer
- 20cc blood
- Metformin prescription and dispensing will be as per clinical care.
- Women will be advised to use barrier method of contraception (ie; condoms, contraceptive jellies or foam, sponge, diaphragm, or cervical cap) for the duration of the study.
Visits 3 and 5 (Weeks 8-10 and 30-34, respectively)
- Urine pregnancy test
- A 10 day course of vaginal progesterone to allow scheduling of EMBx's time points specified under visit 1
Visits 4 and 6 (Weeks 12 ± 1 week and 36 ± 1 week respectively)
- The procedure specified for baseline (Visit 2) will be repeated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: Endometrin (progesterone 100mg vaginal inserts), Drug: MetforminWomen with PCOS initiating Metformin and exposure to vaginal progesterone for 6-8 days prior ro Endometrium Biopsy |
| B | – | Drug: Endometrin (progesterone 100mg vaginal inserts)Women with PCOS not planning initiating Metformin and exposure to vaginal progesterone for 6-8 days prior to Endometrium Biopsy |
| Women with PCOS who previously initiated metformin | – | –Women with PCOS who initiated metformin at least 3 months prior to enrollment who have completed a 6-10 day course of progesterone |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women will be recruited from the multi-physician Yale Reproductive Endocrinology clinical practice and Yale Fertility Center. Metformin is a routinely employed therapeutic strategy utilized for managing PCOS by practitioners at YFC. Almost 1/3 of the patients with PCOS are not interested in pursuing fertility in the immediate future and it is these patients who will be offered participation in the trial.
Key inclusion criteria (6 listed)
- Premenopausal between 18-42 years of age
- Diagnosed with PCOS as defined by chronic oligo- or amenorrhea (8 menstrual periods annually); biochemical hyperandrogenemia (elevated total or free testosterone) and /or clinical hyperandrogenism (excessive facial hair \&/or acne); exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone <200 ng/dl).
- Acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis) performed within the past 6 months
- Able to provide signed informed consent
- Able to comply with study requirements
Key exclusion criteria (6 listed)
- Known diabetics or those with clinically significant and known pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer)
- Current use of hormonal contraceptives
- Seeking pregnancy; use of fertility drugs within 6 months of study
- Current or recent (within 3 months) use of metformin
- Ingestion of any investigational drug within two months prior to study onset
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 |
|---|---|---|
| Endometrin (progesterone 100mg vaginal inserts)once a day, 6-8 days as specified (prior to each EMBx) | Drug | A, B |
| Metforminper clinical care guidelines | Drug | A |
Primary outcome
It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy
Time frame: baseline
It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy
Time frame: 3 months
It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy
Time frame: 9 months
2 secondary outcomes
blood draw (20mL)
Time frame: on day of EMBx
A combination of quantitative real time PCR, immunohistochemistry, and Western Blot techniques will be utilized for studying endometrial markers of receptivity in the endometrial tissue
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- MedlinePlus related topics: Polycystic Ovary DiseaseLink provided by the sponsor.
- Drug Information available for: MetforminLink provided by the sponsor.
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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.
Lubna Pal, MBBS MRCOG MSc principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovarian Syndrome, run by Yale University 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 6 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 30 Mar 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy (time frame: baseline). The study lists 3 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 30 Mar 2020.