Comparative Trial in Hormone Withdrawal Associated Symptoms

Oral Contraceptive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076582
• Other study ID #: 14567
• Secondary ID: 2009-014911-11
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2010
• Last updated: October 27, 2014
• Start date: April 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyPhilippines: Bureau of Food and DrugsPortugal: National Pharmacy and Medicines InstituteRussia: Ministry of Health of the Russian FederationSouth Korea: Korea Food and Drug Administration (KFDA)Switzerland: Swissmedic-Swiss Agency for Therapeutic ProductsThailand: Ministry of Public HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyVenezuela: The national Institute of Hygiene
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oral Contraceptive

Intervention

Drug:
• EE20/DRSP (YAZ, BAY86-5300)
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)
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Czech Republic,  Germany,  Italy,  Korea, Republic of,  Philippines,  Portugal,  Russian Federation,  Switzerland,  Thailand,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Cycle days 22 - 28 of baseline cycle and cycle 4.	No
Secondary	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),		Cycle days 22 - 28 of baseline cycle and cycle 4	No
Secondary	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),		Cycle days 22 - 28 of baseline cycle and cycle 4	No
Secondary	change from baseline to cycle 4 in maximum intensity of individual hormone withdrawal symptoms on cycle days 22 - 28,		Cycle days 22 - 28 of baseline cycle and cycle 4	No
Secondary	rescue medication consumption		baseline cycle and cycle 4	No
Secondary	bleeding pattern		reference period is 90 days.	No
Secondary	evaluation of questionnaires: Q-LES-Q (short version)		baseline cycle and cycle 4	No
Secondary	Adverse Event collection		up to 10 days after end of cycle 4	Yes
Secondary	heart rate		up to 10 days after end of cycle 4	Yes
Secondary	blood pressure		up to 10 days after end of cycle 4	Yes

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