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

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ClinicalTrials.gov Identifier: NCT01569113
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : June 13, 2013
Sponsor:
Information provided by (Responsible Party):
HRA Pharma

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 Type : Interventional  (Clinical Trial)
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 : March 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Microgynon 30



Primary Outcome Measures :
  1. 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). [ Time Frame: Day 1 to day 21 of intake of microgynon 30 ]

Secondary Outcome Measures :
  1. Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo. [ Time Frame: Day 1 to day 21 of intake of microgynon 30 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569113


Locations
Netherlands
Dinox
Groningen, Netherlands, 9713
Sweden
Karolinska University Hospital Solna
Stockholm, Sweden, SE-171 76
United Kingdom
Chalmers Sexual Health Clinic
Edinburgh, Scotland, United Kingdom, EH3 9ES
Sponsors and Collaborators
HRA Pharma
Investigators
Principal Investigator: Sharon Cameron, MD Chalmers Sexual Health Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT01569113     History of Changes
Other Study ID Numbers: 2914-015
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by HRA Pharma:
ella
ellaOne
quickstart
contraception
combined oral pill
microgynon

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Contraceptive Agents
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral
Ethinyl Estradiol
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital