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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01569113

Enrollment

Registered

2012-04-02

Start date

2012-03-31

Completion date

2012-08-31

Last updated

2013-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Contraception

Keywords

ella, ellaOne, quickstart, contraception, combined oral pill, microgynon

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.

Interventions

DRUGUlipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)

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

DRUGplacebo + ethinylestradiol/levonorgestrel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Netherlands, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026