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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.

Information source: HRA Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Emergency Contraception

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

Phase: Phase 4

Status: Completed

Sponsored by: HRA Pharma

Official(s) and/or principal investigator(s):
Sharon Cameron, MD, Principal Investigator, Affiliation: Chalmers Sexual Health Clinic

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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).

Secondary outcome: Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

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.

Locations and Contacts

Dinox, Groningen 9713, Netherlands

Karolinska University Hospital Solna, Stockholm SE-171 76, Sweden

Chalmers Sexual Health Clinic, Edinburgh, Scotland EH3 9ES, United Kingdom

Additional Information

Starting date: March 2012
Last updated: June 12, 2013

Page last updated: August 23, 2015

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