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Oral ContraceptivePhase 3NCT01076582

Comparative Trial in Hormone Withdrawal Associated Symptoms

A Phase 3 study testing EE20/DRSP (YAZ, BAY86-5300) and Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon) in people with Oral Contraceptive, run by Bayer at 44 sites in 14 countries.

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

This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Oral Contraceptive
What is being tested?
EE20/DRSP (YAZ, BAY86-5300) and Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
592 participants
Where
44 sitesin 14 countries
Study dates
Apr 2010to Oct 2011
Phase
Phase 3
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

  • Subjects aged between 18 and 35 years (inclusive)
  • Smokers with a maximum age of 30 years at time of informed consent
  • Healthy female subjects requesting contraception and currently using a low-dose EE containing oral contraceptives (OC) in a 21-day regimen (for at least three months) and suffering from at least two of the hormone withdrawal associated symptoms headache, pelvic pain and bloating during all three months prior the planned baseline cycle and requiring further OC use
  • To be valid for randomization, the total 7-day composite score of hormone-withdrawal symptoms during the baseline cycle must show an increase of at least 50% during Day 22 - 28 versus the 21-day composite score during Day 1 - 21 (21-day score divided by three [for normalization])
  • History of regular cyclic menstrual periods

Who cannot join

  • Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, or presence or history of prodrome of a thrombosis (e.g. transient ischemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. Hereditary or acquired predisposition for venous or arterial thrombosis, such as APCresistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
  • History of migraine with focal neurological symptoms.
  • Diabetes mellitus with vascular involvement.
  • Obesity (Body Mass Index >32.0 kg/m2)
  • Moderate to severe hypertension (repeated measurements of systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg).
  • Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
Show all 10Show fewer
  • Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
  • Jaundice and / or pruritus related to cholestasis (Gilbert´s syndrome excepted), or history of cholestatic jaundice associated with pregnancy or previous combined OC use
  • Severe renal insufficiency or acute renal failure.
  • Presence or history of liver tumors (benign or malignant), or known or suspected sex-steroid influenced malignancies or premalignant disease (e.g. of the genital organs or the breasts).

Trial locations and contacts

44 sites in 14 countries.

44 sites in 14 countries

Germany6 sites

  • Study site

    Fürth, Bavaria, 90763

  • Study site

    Hanover, Lower Saxony, 30459

  • Study site

    Heidelberg, Baden-Wurttemberg, 69115

  • Study site

    Jena, Thuringia, 07747

  • Study site

    Leipzig, Saxony, 04207

  • Study site

    Magdeburg, Saxony-Anhalt, 39126

Other trials in Germany

Chile5 sites

  • Study site

    Santiago, Santiago Metropolitan, 7510025

  • Study site

    Santiago, Santiago Metropolitan, 836-0156

  • Study site

    Santiago, 838-0456

  • Study site

    Santiago

  • Study site

    Temuco, 4790711

Other trials in Chile

South Korea4 sites

  • Study site

    Seoul, Korea, 100-380

  • Study site

    Seoul, Korea, 138-736

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 135-710

Other trials in South Korea

Colombia3 sites

  • Study site

    Bogotá

  • Study site

    Bucaramanga, Santander Department

  • Study site

    Medellín

Other trials in Colombia

Czechia3 sites

  • Study site

    Brno, 602 00

  • Study site

    Prague, 120 00

  • Study site

    Tábor, 39003

Other trials in Czechia

Italy3 sites

  • Study site

    Florence, 50134

  • Study site

    Milan, 20132

  • Study site

    Siena, 53100

Other trials in Italy

Portugal3 sites

  • Study site

    Coimbra, 3000-061

  • Study site

    Lisbon, Lisbon District, 1649-035

  • Study site

    Porto, 4200-319

Other trials in Portugal

Russia3 sites

  • Study site

    Moscow, 117036

  • Study site

    Moscow, 123995

  • Study site

    Moscow, 177997

Other trials in Russia

Switzerland3 sites

  • Study site

    Basel, Canton of Basel-City, 4031

  • Study site

    Bern, Canton of Bern, 3010

  • Study site

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Thailand3 sites

  • Study site

    Bangkok, Thailand, 10330

  • Study site

    Bangkok, 10700

  • Study site

    Songkhla, Thailand, 90110

Other trials in Thailand

United Kingdom3 sites

  • Study site

    Leeds, West Yorkshire, LS2 9AE

  • Study site

    Liverpool, L20 5DQ

  • Study site

    London, W12 0HS

Other trials in United Kingdom

Argentina2 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1425ASQ

  • Study site

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Philippines2 sites

  • Study site

    Manila

  • Study site

    Pasig

Other trials in Philippines

Venezuela1 site

  • Study site

    Caracas

Other trials in Venezuela

About this study

Official title: A Multi-centre, Randomized, Double-blind, Active Control, Parallel-group, 2-arm Study to Investigate the Effect of Ethinylestradiol / Drospirenone (0.02 mg/3 mg) Oral Contraception in a 24/4 Regimen Compared to Ethinylestradiol / Desogestrel (0.02 mg/0.15 mg) Oral Contraception in a 21/7 Regimen on Hormone Withdrawal Associated Symptoms in Otherwise Healthy Women After 4 Cycles of Treatment

This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.

Being tested
EE20/DRSP (YAZ, BAY86-5300), Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)
Keywords
hormone withdrawal associated symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EE20/DRSP (YAZ, BAY86-5300)Drug

    4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days

  • Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)Drug

    4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days

Study groups in NCT01076582
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: EE20/DRSP (YAZ, BAY86-5300)
Arm 2Active comparatorNot described
Receives: Drug: Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales).

    Measured: Cycle days 22 - 28 of baseline cycle and cycle 4.

Secondary outcomes (9)

  1. change from baseline to cycle 4 in the sum of individual scores during cycle days 22 - 28 (AUC of days 22 - 28 for each score),

    Measured: Cycle days 22 - 28 of baseline cycle and cycle 4

  2. change from baseline to cycle 4 in number of days, where individual hormone withdrawal symptoms are present on cycle days 22 - 28 (i.e. Likert Scale >= 1),

    Measured: Cycle days 22 - 28 of baseline cycle and cycle 4

  3. change from baseline to cycle 4 in maximum intensity of individual hormone withdrawal symptoms on cycle days 22 - 28,

    Measured: Cycle days 22 - 28 of baseline cycle and cycle 4

  4. rescue medication consumption

    Measured: baseline cycle and cycle 4

  5. bleeding pattern

    Measured: reference period is 90 days.

  6. evaluation of questionnaires: Q-LES-Q (short version)

    Measured: baseline cycle and cycle 4

  7. Adverse Event collection

    Measured: up to 10 days after end of cycle 4

  8. heart rate

    Measured: up to 10 days after end of cycle 4

  9. blood pressure

    Measured: up to 10 days after end of cycle 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
592 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01076582
Sponsor's protocol ID
14567
Other IDs
2009-014911-11, 2009
Status last verified
Oct 2014
First submitted
25 Feb 2010
Last updated
28 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EE20/DRSP (YAZ, BAY86-5300) and Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon) in people with Oral Contraceptive, run by Bayer at 44 sites in 14 countries.

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 5 inclusion and 10 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Germany, Chile, South Korea, Colombia, Czechia and 9 more countries. 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 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?

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?

Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales). (time frame: Cycle days 22 - 28 of baseline cycle and cycle 4.). 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 NCT01076582.

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 28 Oct 2014.

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