Polycystic Ovary SyndromePhase 4BEYAZ-PCOSNCT01360996
Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
A Phase 4 study testing 3 mg DRSP/20 μg EE in people with Polycystic Ovary Syndrome, run by Woman's at 1 site in United States.
Trial summary
The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS effectively reduces circulating androgens. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- 3 mg DRSP/20 μg EE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2015
- Phase
- Phase 4
- 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 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- •Adult female-16 years to 35 years of age who have been diagnosed with PCOS desiring contraception
- Actual BMI >18 to <35kg/ m2
- Written consent for participation in the study
- Patient completed lactation
Who cannot join
- Metabolic abnormalities requiring pharmacological intervention (except controlled thyroid disease)
- Uncontrolled hypertension
- Cancer or history of hormone-dependent cancer
- History of cholestasis
- Presence of contradictions for OC administration
- Personal history of cardiovascular events.
Show all 16Show fewer
- Use of drugs known to exacerbate glucose tolerance.
- No prescription or over-the-counter weight-loss drugs
- Diabetes
- Use of medications that affect blood pressure or lipid profile
- Smoking in past 6 months
- Known thrombogenic mutations (e.g. Factor V Leiden)
- Current or history of deep venous thrombosis/pulmonary embolism
- Major surgery with prolonged immobilization
- Injectable hormonal contraceptive use within 6 months
- Use of hormonal (e.g., oral contraceptive [OC] pill) or insulin-sensitizing medication unless willing to cease medications for 3 months before study measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive Clinical and Hormonal Effects of Ethinylestradiol Combined With Drospirenone (EE/DRSP) in Women With Polycystic Ovary Syndrome (PCOS): Impact of Body Weight and Relevance to Hyperandrogenism
The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS effectively reduces circulating androgens. Although OCs are the most common and one of the oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of PCOS women with different body mass index (BMI) are limited. This study is being done to compare the hormone and metabolic changes after treatment with low-dose oral birth control regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS with different body weights.
Read the detailed description
Clinically, polycystic ovary syndrome (PCOS) is a heterogeneous disorder of functional androgen excess and the features of PCOS can run through a spectrum of severity. The optimal modality for long-term treatment of PCOS should positively influence androgen synthesis, sex hormone binding globulin (SHBG) production, insulin sensitivity, the lipid profile, and clinical symptoms including hirsutism and irregular menstrual cycles. Combined oral contraceptives have been a key component of the chronic treatment of women with PCOS; improving androgen excess and regulating menstrual cycles. The effect of OCs on ovarian folliculogenesis significantly decreases androgen production. This mechanism was confirmed in both healthy women and women with PCOS. In obese patients with PCOS, it is likely that the suppression of androgen production is not as significant. It is thus possible to hypothesize that the effects of OCs in PCOS could be dependent on body weight and what is needed is a head-to-head comparison. The aim of this study is to compare the effect of 6 months of a low-dose oral contraceptive regimen of 24/4 DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg on androgen profiles, cardiometabolic measures, B-vitamin status, and menstrual cycle regulation in three groups, normal (BMI 18-24.9 kg/ m2) overweight (BMI 25-29.9 kg/ m2) and obese (BMI 30-35 kg/ m2) women with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- 3 mg DRSP/20 μg EE
- Keywords
- PCOS
- 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.
3 mg DRSP/20 μg EEDrug
Also called folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive, BeYaz
1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
| Study group | Role | What they receive |
|---|---|---|
| 3 mg DRSP/20 μg EE--normal weight | Experimental | Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
Normal weight -BMI 18-24.9 kg/ m2 Receives: Drug: 3 mg DRSP/20 μg EE |
| 3 mg DRSP/20 μg EE- Overweight | Experimental | Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 25-29.9 kg/ m2 Receives: Drug: 3 mg DRSP/20 μg EE |
| 3 mg DRSP/20 μg EE- Grade 1 obese | Experimental | Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 30-34.9 kg/ m2 Receives: Drug: 3 mg DRSP/20 μg EE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Assessment of Hyperandrogenism
The primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units.
FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100
Measured: 24 weeks
Secondary outcomes (6)
Cardiometabolic Measures
Values represent blood pressure at 24 weeks.
Measured: 24 weeks
Post Therapy BMI.
Post-treatment body mass index at 24 weeks
Measured: 24 weeks
Biochemical Indicator of B-vitamin Status
Post-treatment in folate concentrations after 24 weeks of treatment
Measured: 24 weeks
Menstrual Cycle Regularity
Post treatment menstrual frequency over 24 weeks normalized to number of menses per year ..
Measured: 24 weeks
Adrenal Androgen DHEAS
Post-treatment levels of adrenal androgen DHEAS
Measured: 24 weeks
Oral Disposition Index
Post-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2015
- Study completionFeb 2015
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 Ovary SyndromeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Principal investigator, Karen Elkind-Hirsch, Woman's
- Investigators
- Karen E Elkind-Hirsch, M.Sc.,Ph.D., Principal investigator, Woman's Hospital, LouisianaMartha Paterson, M.D., Principal investigator, Woman's Hospital Metabolic Health Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360996
- Sponsor's protocol ID
- RP 11-003
- Acronym
- BEYAZ-PCOS
- Status last verified
- Mar 2017
- First submitted
- 25 May 2011
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Clinical and Hormonal Effects of Ethinylestradiol Combined With Drospirenone (EE/DRSP) in Women With Polycystic Ovary Syndrome (PCOS): Impact of Body Weight and Relevance to Hyperandrogenism
- ClinicalTrials.gov ID
- NCT01360996
- Acronym / sponsor ID
- BEYAZ-PCOS / RP 11-003
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- Aug 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 May 2011 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS effectively reduces circulating androgens. Although OCs are the most common and one of the oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of PCOS women with different body mass index (BMI) are limited. This study is being done to compare the hormone and metabolic changes after treatment with low-dose oral birth control regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS with different body weights.
Detailed description
Clinically, polycystic ovary syndrome (PCOS) is a heterogeneous disorder of functional androgen excess and the features of PCOS can run through a spectrum of severity. The optimal modality for long-term treatment of PCOS should positively influence androgen synthesis, sex hormone binding globulin (SHBG) production, insulin sensitivity, the lipid profile, and clinical symptoms including hirsutism and irregular menstrual cycles. Combined oral contraceptives have been a key component of the chronic treatment of women with PCOS; improving androgen excess and regulating menstrual cycles. The effect of OCs on ovarian folliculogenesis significantly decreases androgen production. This mechanism was confirmed in both healthy women and women with PCOS. In obese patients with PCOS, it is likely that the suppression of androgen production is not as significant. It is thus possible to hypothesize that the effects of OCs in PCOS could be dependent on body weight and what is needed is a head-to-head comparison. The aim of this study is to compare the effect of 6 months of a low-dose oral contraceptive regimen of 24/4 DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg on androgen profiles, cardiometabolic measures, B-vitamin status, and menstrual cycle regulation in three groups, normal (BMI 18-24.9 kg/ m2) overweight (BMI 25-29.9 kg/ m2) and obese (BMI 30-35 kg/ m2) women with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 mg DRSP/20 μg EE--normal weight | Experimental | Drug: 3 mg DRSP/20 μg EEFolate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive Normal weight -BMI 18-24.9 kg/ m2 |
| 3 mg DRSP/20 μg EE- Overweight | Experimental | Drug: 3 mg DRSP/20 μg EEFolate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive BMI 25-29.9 kg/ m2 |
| 3 mg DRSP/20 μg EE- Grade 1 obese | Experimental | Drug: 3 mg DRSP/20 μg EEFolate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive BMI 30-34.9 kg/ m2 |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- •Adult female-16 years to 35 years of age who have been diagnosed with PCOS desiring contraception
Key exclusion criteria (16 listed)
- Metabolic abnormalities requiring pharmacological intervention (except controlled thyroid disease)
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 |
|---|---|---|
| 3 mg DRSP/20 μg EEAlso: folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive, BeYaz1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only | Drug | 3 mg DRSP/20 μg EE- Grade 1 obese, 3 mg DRSP/20 μg EE- Overweight, 3 mg DRSP/20 μg EE--normal weight |
Primary outcome
Biochemical Assessment of Hyperandrogenism
Time frame: 24 weeks
The primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units. FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100
6 secondary outcomes
Cardiometabolic Measures
Time frame: 24 weeks
Post Therapy BMI.
Time frame: 24 weeks
Biochemical Indicator of B-vitamin Status
Time frame: 24 weeks
Menstrual Cycle Regularity
Time frame: 24 weeks
Adrenal Androgen DHEAS
Time frame: 24 weeks
Oral Disposition Index
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Karen E Elkind-Hirsch, M.Sc.,Ph.D. principal investigator
Woman's Hospital, Louisiana
Martha Paterson, M.D. principal investigator
Woman's Hospital Metabolic Health Clinic
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 3 mg DRSP/20 μg EE in people with Polycystic Ovary Syndrome, run by Woman's 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 4 inclusion and 16 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 31 Mar 2017. 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.
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?
Yes. Results are posted in the registry (first posted 31 Mar 2017). 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?
Biochemical Assessment of Hyperandrogenism (time frame: 24 weeks). 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 31 Mar 2017.