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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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.

United States1 site

Woman's Hospital
Baton Rouge, Louisiana, 70815

Other trials in United States

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 groups in NCT01360996
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.

Aug 2011Feb 2015

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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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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All Polycystic Ovary Syndrome trials

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.

Detailed description

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

Results posted to the registry on 31 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3 mg DRSP/20 μg EE--normal Weight	20	14
3 mg DRSP/20 μg EE- Overweight	21	18
3 mg DRSP/20 μg EE- Grade 1 Obese	23	21

Primary outcome: Biochemical Assessment of Hyperandrogenism

Time frame: 24 weeks. Mean (Standard Deviation). Unit: Index

Measure	Non-Obese n = 32	Obese n = 21
Value	0.7 (0.5)	0.7 (0.45)

Non-Obese vs Obese: p <.0001, ANOVA

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3 mg DRSP/20 μg EE--normal Weight	0 of 20 (0%)	0 of 20 (0%)	Not reported
3 mg DRSP/20 μg EE- Overweight	0 of 21 (0%)	0 of 21 (0%)	Not reported
3 mg DRSP/20 μg EE- Grade 1 Obese	0 of 23 (0%)	0 of 23 (0%)	Not reported

Limitations and caveats (from the sponsor): Limitations include evaluation after 24 weeks in a limited number of patients, The time may be too short and sample size too small to measure differences between normal and overweight PCOS women and the use of indirect measures of insulin action.

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

Related trials for Polycystic Ovary Syndrome

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Recruiting
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.

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?

On the ClinicalTrials.gov record for NCT01360996.

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.