PCOSPhase 4NCT03236740
OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS
A Phase 4 study testing Ethinyl Estradiol-cyprosterone acetate and Metformin Hydrochloride in people with PCOS, run by S.C.B. Medical College and Hospital at 1 site in India.
Trial summary
This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Ethinyl Estradiol-cyprosterone acetate and Metformin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2017to 15 Mar 2018
- Phase
- Phase 4
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with PCOS according to the Rotterdam criteria
Who cannot join
- Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
- Medical or surgical treatment of PCOS during the previous 3 months
- Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
- Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months)
- Inability to understand the proposal of the study precluding effective informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Doppler Analysis of Ovarian Stromal Blood Flow Changes After Treatment With Metformin Versus Ethinylestradiol-cyproterone Acetate in Women With Polycystic Ovarian Syndrome
This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal parameters post-treatment.
- Conditions
- PCOS
- Being tested
- Ethinyl Estradiol-cyprosterone acetate, Metformin Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinyl Estradiol-cyprosterone acetateDrug
Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.
Metformin HydrochlorideDrug
Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Metformin 500mg bid in morning and evening after meals to be taken for 6 months. Receives: Drug: Metformin Hydrochloride |
| OCP | Active comparator | OCP containing 35 microgram ethinylestradiol and 2-milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill. OCP to be taken for 6 months. Receives: Drug: Ethinyl Estradiol-cyprosterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ovarian stromal blood flow by using Doppler
By means of color and power Doppler flow imaging, color signals will be searched in the ovarian stroma away from the ovarian surface and not adjacent to the wall of a follicle. Areas of maximum color intensity, representing the greatest Doppler frequency shifts, will be chosen for pulsed Doppler examination.
Measured: 6 months
Secondary outcomes (11)
Change in BMI as measured in kg/m2
Measured: 6 months
Improvement in hirsutism measured by Modified Ferriman and Gallwey scores
Measured: 6 months
Improvement in menstrual cycle pattern
Measured: 6 months
Change in waist circumference (cm)
Measured: 6 months
Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml)
Measured: 6 months
Change in blood level of Testosterone (nmol/L)
Measured: 6 months
Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)
Measured: 6 months
Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)
Measured: 6 months
Changes in fasting serum insulin levels (mIU/L)
Measured: 6 months
Changes in fasting serum glucose levels (mg/dL)
Measured: 6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Aug 2017
- Primary completion1 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.C.B. Medical College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priyadarshini Tripathy, MD, Principal investigator, SCB Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236740
- Sponsor's protocol ID
- OG/2017/12
- Status last verified
- Mar 2018
- First submitted
- 29 Jul 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Analysis of Ovarian Stromal Blood Flow Changes After Treatment With Metformin Versus Ethinylestradiol-cyproterone Acetate in Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT03236740
- Acronym / sponsor ID
- OG/2017/12
- Conditions
- PCOS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- S.C.B. Medical College and HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 2 Aug 2017 (actual)
- 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.
This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal parameters post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin HydrochlorideMetformin 500mg bid in morning and evening after meals to be taken for 6 months. |
| OCP | Active comparator | Drug: Ethinyl Estradiol-cyprosterone acetateOCP containing 35 microgram ethinylestradiol and 2-milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill. OCP to be taken for 6 months. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women diagnosed with PCOS according to the Rotterdam criteria
Key exclusion criteria (5 listed)
- Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
- Medical or surgical treatment of PCOS during the previous 3 months
- Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
- Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months)
- Inability to understand the proposal of the study precluding effective informed consent
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 |
|---|---|---|
| Ethinyl Estradiol-cyprosterone acetateEthinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants. | Drug | OCP |
| Metformin HydrochlorideMetformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants. | Drug | Metformin |
Primary outcome
Changes in ovarian stromal blood flow by using Doppler
Time frame: 6 months
By means of color and power Doppler flow imaging, color signals will be searched in the ovarian stroma away from the ovarian surface and not adjacent to the wall of a follicle. Areas of maximum color intensity, representing the greatest Doppler frequency shifts, will be chosen for pulsed Doppler examination.
11 secondary outcomes
Change in BMI as measured in kg/m2
Time frame: 6 months
Improvement in hirsutism measured by Modified Ferriman and Gallwey scores
Time frame: 6 months
Improvement in menstrual cycle pattern
Time frame: 6 months
Change in waist circumference (cm)
Time frame: 6 months
Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml)
Time frame: 6 months
Change in blood level of Testosterone (nmol/L)
Time frame: 6 months
Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)
Time frame: 6 months
Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)
Time frame: 6 months
Changes in fasting serum insulin levels (mIU/L)
Time frame: 6 months
Changes in fasting serum glucose levels (mg/dL)
Time frame: 6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 6 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 20 Mar 2018.
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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.
Priyadarshini Tripathy, MD principal investigator
SCB Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ethinyl Estradiol-cyprosterone acetate and Metformin Hydrochloride in people with PCOS, run by S.C.B. Medical College and Hospital at 1 site in India.
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 1 inclusion and 5 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 20 Mar 2018. 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 India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in ovarian stromal blood flow by using Doppler (time frame: 6 months). 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 20 Mar 2018.