Clinical Study of a Conventional and Flexible Extended Oral Contraceptive of EE/DRSP With or Without Metafolin in Latin America

NCT01331655 | Withdrawn Phase 3

• 1 other identifier: 14700
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this three-arm study is to evaluate the effect of a flexible extended regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance with daily pill intake when the investigational product is provided in a blister package or a compliance aiding dispenser with a pill reminder function. The third treatment arm will be a reference comparator arm of a standard 24+4 regimen of the identical hormone combination.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Number of bleeding days

  Approximately 1 year

Secondary Outcomes (3)

• Difference in the number of missed tablets between Arms A and B

  Approximately 1 year

• Bleeding pattern and cycle control parameters

  Approximately 1 year

• Number of cycles per subject

  Approximately 1 year

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: EE20/DRSP (BAY86-5300)

Arm 2

EXPERIMENTAL

Drug: EE20/DRSP/L-5-MTHF (BAY98-7071)

Arm 3

ACTIVE COMPARATOR

Drug: EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660)

Interventions

EE20/DRSP (BAY86-5300) DRUG

Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP (1 tablet/day); up to 120-day treatment period followed by a 4-day tablet-free interval

Arm 1

EE20/DRSP/L-5-MTHF (BAY98-7071) DRUG

Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium (1 tablet/day) up to 120-day treatment period followed by a 4-day tablet-free interval

Arm 2

EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660) DRUG

Day 1-24: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium per tablet (1 tablet/day) Day 25-28: tablets with 0.451 mg levomefolate calcium (1 tablet/day)

Arm 3

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection

You may not qualify if:

• Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
• Body mass index (BMI) \>/= 30.0 kg/m2
• Presence or a history of venous or arterial thrombotic/thromboembolic events
• Repeated measurements of systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg
• Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous combined oral contraceptive (COC) use
• Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
• Severe dyslipoproteinemia
• Malignant or premalignant disease
• Uncontrolled thyroid disorder
• Chronic inflammatory bowel disease

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Interventions

5-methyltetrahydrofolate

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 8, 2011
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2014-07