Comparative Trial in Hormone Withdrawal Associated Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01076582
First received: February 25, 2010
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Oral Contraceptive
Drug: EE20/DRSP (YAZ, BAY86-5300)
Drug: Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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), [ Time Frame: Cycle days 22 - 28 of baseline cycle and cycle 4 ] [ Designated as safety issue: No ]
  • 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), [ Time Frame: Cycle days 22 - 28 of baseline cycle and cycle 4 ] [ Designated as safety issue: No ]
  • change from baseline to cycle 4 in maximum intensity of individual hormone withdrawal symptoms on cycle days 22 - 28, [ Time Frame: Cycle days 22 - 28 of baseline cycle and cycle 4 ] [ Designated as safety issue: No ]
  • rescue medication consumption [ Time Frame: baseline cycle and cycle 4 ] [ Designated as safety issue: No ]
  • bleeding pattern [ Time Frame: reference period is 90 days. ] [ Designated as safety issue: No ]
  • evaluation of questionnaires: Q-LES-Q (short version) [ Time Frame: baseline cycle and cycle 4 ] [ Designated as safety issue: No ]
  • Adverse Event collection [ Time Frame: up to 10 days after end of cycle 4 ] [ Designated as safety issue: Yes ]
  • heart rate [ Time Frame: up to 10 days after end of cycle 4 ] [ Designated as safety issue: Yes ]
  • blood pressure [ Time Frame: up to 10 days after end of cycle 4 ] [ Designated as safety issue: Yes ]

Enrollment: 592
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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
Active Comparator: Arm 2 Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076582

  Show 45 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01076582     History of Changes
Other Study ID Numbers: 14567, 2009-014911-11
Study First Received: February 25, 2010
Last Updated: June 25, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Philippines: Bureau of Food and Drugs
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Health of the Russian Federation
South Korea: Korea Food and Drug Administration (KFDA)
Switzerland: Swissmedic-Swiss Agency for Therapeutic Products
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Venezuela: The national Institute of Hygiene

Keywords provided by Bayer:
hormone withdrawal associated symptoms

Additional relevant MeSH terms:
Hormones
Ethinyl Estradiol
Desogestrel
Drospirenone and ethinyl estradiol combination
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogens
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Progestins

ClinicalTrials.gov processed this record on September 16, 2014