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

Emergency Contraception Clinical Trial

Official title:

A Prospective, Randomized, Double-blind Parallel-arm, Placebo-controlled Study to Assess the Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® (Ulipristal Acetate 30 mg) or Placebo.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569113
• Other study ID #: 2914-015
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2012
• Last updated: June 12, 2013
• Start date: March 2012
• Est. completion date: August 2012

Study information

• Verified date: June 2013
• Source: HRA Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergency Contraception

Intervention

Drug:
• Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)
UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
• placebo + ethinylestradiol/levonorgestrel
placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake

Locations

Country	Name	City	State
Netherlands	Dinox	Groningen
Sweden	Karolinska University Hospital Solna	Stockholm
United Kingdom	Chalmers Sexual Health Clinic	Edinburgh	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
HRA Pharma

Countries where clinical trial is conducted

Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with a Hoogland score consistent with ovarian quiescence (=3) after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo).		Day 1 to day 21 of intake of microgynon 30	No
Secondary	Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score =3) after the intake of ellaOne® or placebo.		Day 1 to day 21 of intake of microgynon 30	No