Emergency ContraceptionPhase 4NCT01569113
Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
A Phase 4 study testing Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) in people with Emergency Contraception, run by HRA Pharma at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emergency Contraception
- What is being tested?
- Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2012to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Chalmers Sexual Health Clinic
Edinburgh, Scotland, EH3 9ES
About this study
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.
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.
- Conditions
- Emergency Contraception
- Being tested
- Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon), placebo + ethinylestradiol/levonorgestrel
- Keywords
- ella, ellaOne, quickstart, contraception, combined oral pill, microgynon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)Drug
Also called ellaOne + Microgynon 30
UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
placebo + ethinylestradiol/levonorgestrelDrug
Also called Microgynon 30
placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
| Study group | Role | What they receive |
|---|---|---|
| ellaOne + microgynon 30 | Experimental | Not described Receives: Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) |
| placebo + microgynon 30 | Placebo comparator | Not described Receives: Drug: placebo + ethinylestradiol/levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1 to day 21 of intake of microgynon 30
Secondary outcomes (1)
Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.
Measured: Day 1 to day 21 of intake of microgynon 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Cameron, MD, Principal investigator, Chalmers Sexual Health Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569113
- Sponsor's protocol ID
- 2914-015
- Status last verified
- Jun 2013
- First submitted
- 30 Mar 2012
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25994664
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01569113
- Acronym / sponsor ID
- 2914-015
- Conditions
- Emergency Contraception
- Keywords
- ella, ellaOne, quickstart, contraception, combined oral pill, microgynon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ellaOne + microgynon 30 | Experimental | Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) |
| placebo + microgynon 30 | Placebo comparator | Drug: placebo + ethinylestradiol/levonorgestrel |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)Also: ellaOne + Microgynon 30UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake | Drug | ellaOne + microgynon 30 |
| placebo + ethinylestradiol/levonorgestrelAlso: Microgynon 30placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake | Drug | placebo + microgynon 30 |
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).
Time frame: Day 1 to day 21 of intake of microgynon 30
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
- Derived from this study: PubMed 25994664Cameron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Cameron, MD principal investigator
Chalmers Sexual Health Clinic
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) in people with Emergency Contraception, run by HRA Pharma at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01569113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.