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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HRA Pharma
ClinicalTrials.gov Identifier:
NCT01569113
First received: March 30, 2012
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by HRA Pharma:

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). [ Time Frame: Day 1 to day 21 of intake of microgynon 30 ] [ Designated as safety issue: No ]

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. [ Time Frame: Day 1 to day 21 of intake of microgynon 30 ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT01569113     History of Changes
Other Study ID Numbers: 2914-015
Study First Received: March 30, 2012
Last Updated: June 12, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on November 25, 2014