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Synthetic vs Natural Estrogen in Combined Oral Contraception

NCT02352090 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-06-22

Study results available
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Summary

The main objective of the study is to compare the metabolic effects of natural estradiol and synthetic ethinylestradiol used in combined oral contraception in healthy women. A progestin-only preparation will be used in comparison. The main goal is to study the effects on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP). Our hypothesis is that the natural estradiol preparation will influence blood glucose levels, markers of coagulation and chronic inflammation less than the ethinylestradiol preparation. The progestin-only preparation will not effect these parameters.

Conditions

  • Contraception

Interventions

DRUG

Ethinyl estradiol / dienogest

One tablet orally for 9 weeks, continuous use

DRUG

Estradiol valerate / dienogest

One tablet orally for 9 weeks, continuous use

DRUG

Dienogest

One tablet orally for 9 weeks, continuous use

Sponsors & Collaborators

  • Oulu University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Oskari Heikinheimo, Prof., PhD., MD. · Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki Univeristy, Medical Faculty

  • Juha Tapanainen, Prof., PhD, MD. · Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki Univeristy, Medical Faculty

  • Terhi Piltonen, PhD, MD · Oulu University Hospital, Department of Gynecology and Obstetrics

  • Annina Haverinen, MD, PhD student · Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki University, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • Finland

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 NCT02352090 on ClinicalTrials.gov