Synthetic vs Natural Estrogen in Combined Oral Contraception (SYLVI)

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Drug: Dienogest; Drug: Ethinyl estradiol / dienogest; Drug: Estradiol valerate / dienogest

Study type: Interventional

Funder types: Other

Identifiers

NCT02352090

SYLVI030785

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 19-24.9, regular menstrual cycles (21-35 days), a minimum of 2 months without any hormonal contraceptives, no contraindications for use of hormonal contraception

Exclusion criteria

• Polycystic ovaries, hypertension, smoking, alcohol abuse, pregnancy, lactation, abnormal result in pre-screening 2h oral glucose tolerance test, regular medications

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

59 participants in 3 patient groups

Synthetic estrogen + progestin

Experimental group

Description:

Ethinyl estradiol / dienogest

Treatment:

Drug: Ethinyl estradiol / dienogest

Natural estrogen + progestin

Experimental group

Description:

Estradiol valerate / dienogest

Treatment:

Drug: Estradiol valerate / dienogest

Progestin-Only

Active Comparator group

Description:

Dienogest

Treatment:

Drug: Dienogest