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"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"

NCT02957630 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2018-02-05

No results posted yet for this study

Summary

The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.

Conditions

  • Contraception
  • Liver Metabolism
  • Hemostasis Parameter

Interventions

DRUG

15 mg E4/3 mg DRSP

15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

DRUG

30 mcg EE/150 mcg LNG

30 mcg EE combined with 150 mcg LNG administered in a 21/7-day regimen (i.e. 21 days of yellow active tablets followed by 7 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

DRUG

20 mcg EE/3 mg DRSP

20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

Sponsors & Collaborators

  • Estetra

    lead INDUSTRY

Principal Investigators

  • Christine Klipping · Dinox BV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-10-09
Completion
2017-10-09

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02957630 on ClinicalTrials.gov