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

Sponsor

HRA Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01569113

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

25.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Emergency Contraception	Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) Drug: placebo + ethinylestradiol/levonorgestrel	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ellaOne + microgynon 30	Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake Other Names: ellaOne + Microgynon 30
Placebo Comparator: placebo + microgynon 30	Drug: placebo + ethinylestradiol/levonorgestrel placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake Other Names: Microgynon 30

Arm

Intervention/Treatment

Experimental: ellaOne + microgynon 30

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

UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake

Other Names:

ellaOne + Microgynon 30

Placebo Comparator: placebo + microgynon 30

Drug: placebo + ethinylestradiol/levonorgestrel

placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake

Other Names:

Microgynon 30

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dinox	Groningen		Netherlands	9713
2	Karolinska University Hospital Solna	Stockholm		Sweden	SE-171 76
3	Chalmers Sexual Health Clinic	Edinburgh	Scotland	United Kingdom	EH3 9ES