Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.

HRA Pharma

Status and phase: Completed; Phase 4

Conditions: Emergency Contraception

Treatments: Drug: placebo + ethinylestradiol/levonorgestrel; Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01569113

2914-015

Details and patient eligibility

About

The purposes of this study are to compare the effects on ovarian activity of quick starting a Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.

Enrollment: 76 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy women aged 18-35 years old
• BMI < 30 Kg/m2
• Not at risk of pregnancy
• No use of progesterone-only-pill for 3 months before start of treatment cycle
• No use of implant hormonal contraception for 3 months before start of treatment cycle
• No use of levonorgestrel intrauterine system for 3 months before start of treatment cycle
• No use of depo provera for 12 months before start of treatment cycle
• Able to give informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

ellaOne + microgynon 30

Experimental group

Treatment:

Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)

placebo + microgynon 30

Placebo Comparator group

Treatment:

Drug: placebo + ethinylestradiol/levonorgestrel