Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
This study is currently recruiting participants.
Verified March 2012 by HRA Pharma
Sponsor:
HRA Pharma
Information provided by (Responsible Party):
HRA Pharma
ClinicalTrials.gov Identifier:
NCT01569113
First received: March 30, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
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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 ]
| Estimated Enrollment: | 85 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569113
Contacts
| Contact: Sharon Cameron, MD | +44 131 332 54 74 | sharon.cameron@ed.ac.uk |
Locations
| Netherlands | |
| Dinox | Recruiting |
| Groningen, Netherlands, 9713 | |
| Principal Investigator: Christine Klipping, MD | |
| Sweden | |
| Karolinska University Hospital Solna | Not yet recruiting |
| Stockholm, Sweden, SE-171 76 | |
| Principal Investigator: Kristina Gemzell Danielsson, MD | |
| United Kingdom | |
| Chalmers Sexual Health Clinic | Not yet recruiting |
| Edinburgh, Scotland, United Kingdom, EH3 9ES | |
| Principal Investigator: Sharon Cameron, MD | |
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: | March 30, 2012 |
| 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:
|
Emergencies Disease Attributes Pathologic Processes Contraceptive Agents Levonorgestrel Ethinyl Estradiol-Norgestrel Combination Ethinyl estradiol, levonorgestrel drug combination Contraceptives, Oral Contraceptives, Oral, Combined Ethinyl Estradiol Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital |
ClinicalTrials.gov processed this record on May 16, 2013