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

NCT01569113 — Phase 4, Completed, 76 participants, HRA Pharma

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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.

Registry	NCT01569113
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	76 (Actual)
Sponsor	HRA Pharma (Industry)
Conditions	Emergency Contraception
Interventions	Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon), placebo + ethinylestradiol/levonorgestrel (Drug)
Dates	start 2012-03-01, primary completion 2012-08-01, completion 2012-08-01, first posted 2012-04-02, last updated 2013-06-13
Locations	3 sites in Netherlands, Sweden, United Kingdom

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
ellaOne + microgynon 30	Experimental	Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)
placebo + microgynon 30	Placebo comparator	Drug: placebo + ethinylestradiol/levonorgestrel

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

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: Female, ages: 18 Years to 35 Years, accepts healthy volunteers

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.

+Locations (3)

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

+Publications

Results publication: Cameron ST, Berger C, Michie L, Klipping C, Gemzell-Danielsson K. The effects on ovarian activity of ulipristal acetate when 'quickstarting' a combined oral contraceptive pill: a prospective, randomized, double-blind parallel-arm, placebo-controlled study. Hum Reprod. 2015 Jul;30(7):1566-72. doi: 10.1093/humrep/dev115. Epub 2015 May 20. PMID 25994664

+Investigators

Sharon Cameron, MD, Principal investigator, Chalmers Sexual Health Clinic