NCT02352090

Synthetic vs Natural Estrogen in Combined Oral Contraception

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2015-02-02
• Last updated: 2023-06-22
• Results posted: 2021-06-29

Locations

2 sites across 1 country: Finland