CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
Ethinyl estradiol / dienogest +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02352090
NCT02352090Phase 4Completed
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Synthetic vs Natural Estrogen in Combined Oral Contraception- Effect on Insulin Sensitivity, Coagulation, Inflammation and Endometrium - a Comparison With a Progestin-only Preparation.

Helsinki University Central Hospital·interventional·Posted Feb 2, 2015·Updated Jun 22, 2023

In Brief

A Phase 4 clinical trial evaluating Ethinyl estradiol / dienogest, Estradiol valerate / dienogest, and 1 other intervention for Contraception. Completed, enrolled 59 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesFinland
CollaboratorsOulu University Hospital

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2, 2015
Enrollment StartApr 1, 2015
Primary CompletionDec 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.4 years ago

Interventions

Ethinyl estradiol / dienogestdrug

One tablet orally for 9 weeks, continuous use

Estradiol valerate / dienogestdrug

One tablet orally for 9 weeks, continuous use

Dienogestdrug

One tablet orally for 9 weeks, continuous use