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Oral ContraceptivePhase 3NCT00778609

Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache

A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027) in people with Oral Contraceptive and Headache, run by Bayer at 63 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Oral Contraceptive, Headache, Pelvic Pain
What is being tested?
EV/DNG (Qlaira, BAY86-5027)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
449 participants
Where
63 sitesin 9 countries
Study dates
Dec 2008to Dec 2010
Phase
Phase 3
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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 and 50 years (inclusive) at visit 1, for smokers up to 35 years (inclusive)
  • Otherwise healthy female subjects requesting contraception and currently using a levonorgestrel, gestodene or desogestrel containing oral contraceptive in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average value of >/= 35 mm for the 3 highest values on a visual analogue scale during cycle days 22-28.
  • Normal or clinically insignificant cervical smear not requiring further follow up (or a normal result obtained within the last 6 months before screening)
  • Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.

Who cannot join

  • Women with any contraindication for oral contraceptive use

Trial locations and contacts

63 sites in 9 countries.

63 sites in 9 countries

France13 sites

  • Study site

    Brignoles, 83170

  • Study site

    Maison Lafitte, 78600

  • Study site

    Nancy, 54042

  • Study site

    Nantes, 44000

  • Study site

    Nantes, 44093

  • Study site

    Olivet, 45160

  • Study site

    Paris, Paris, 75018

  • Study site

    Paris, 75007

  • Study site

    Paris, 75015

  • Study site

    Saint-Germain-en-Laye, 78100

  • Study site

    Seclin, 59113

  • Study site

    Tarare, 69170

  • Study site

    Toulouse, 31000

Other trials in France

Australia11 sites

  • Study site

    Adelaide, South Australia, 5005

  • Study site

    Ashfield, New South Wales, 2031

  • Study site

    Blacktown, New South Wales, 2148

  • Study site

    Caringbah, New South Wales, 2229

  • Study site

    Clayton, Victoria, 3163

  • Study site

    Fortitude Valley, Queensland, 4006

  • Study site

    Kipparing, Queensland, 4021

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Norwood, South Australia, 5065

  • Study site

    Subiaco, Western Australia, 6008

  • Study site

    Sydney, New South Wales, 2031

Other trials in Australia

Germany11 sites

  • Study site

    Bochum, North Rhine-Westphalia, 44787

  • Study site

    Dresden, Saxony, 01067

  • Study site

    Essen, North Rhine-Westphalia, 45127

  • Study site

    Frankfurt am Main, Hesse, 60322

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 22359

  • Study site

    Hanover, Lower Saxony, 30459

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Lübeck, Schleswig-Holstein, 23538

  • Study site

    Magdeburg, Saxony-Anhalt, 39126

  • Study site

    Rheinstetten, Baden-Wurttemberg, 76287

  • Study site

    Wuppertal, North Rhine-Westphalia, 42103

Other trials in Germany

Spain6 sites

  • Study site

    Barcelona, Barcelona, 08013

  • Study site

    Barcelona, Catalonia, 08003

  • Study site

    Benidorm, Alicante, 03503

  • Study site

    Gijón, Principality of Asturias, 33212

  • Study site

    Madrid, Madrid, 28001

  • Study site

    Petrel, Alicante, 03610

Other trials in Spain

United Kingdom6 sites

  • Study site

    Cheadle, Cheshire, SK8 5LL

  • Study site

    Glasgow, Stratchclyde, G45 9AW

  • Study site

    London, W12 0NN

  • Study site

    Northwood, Middlesex, HA6 2RN

  • Study site

    Nottingham, Nottinghamshire, NG2 4PJ

  • Study site

    Weston-super-Mare, North Somerset, BS23 4BP

Other trials in United Kingdom

Finland5 sites

  • Study site

    Helsinki, 00100

  • Study site

    Helsinki, 00260

  • Study site

    Helsinki, 00350

  • Study site

    Kuopio, 70100

  • Study site

    Kuopio, 70110

Other trials in Finland

Mexico4 sites

  • Study site

    Hermosillo, Sonora, 83100

  • Study site

    México, State of Mexico, 06700

  • Study site

    Mexico City, 3100

  • Study site

    México, D.F., 07760

Other trials in Mexico

Switzerland4 sites

  • Study site

    Basel, Canton of Basel-City, 4031

  • Study site

    Bern, Canton of Bern, 3010

  • Study site

    Bern, 3013

  • Study site

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Thailand3 sites

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Microgynon on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment

The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).

Being tested
EV/DNG (Qlaira, BAY86-5027), Encapsulated Microgynon + Placebo
Keywords
Combined Oral Contraceptives, Pelvic Pain, Headache
Medical subject headings
Headache, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EV/DNG (Qlaira, BAY86-5027)Drug

    Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval

  • Encapsulated Microgynon + PlaceboDrug

    Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo

Study groups in NCT00778609
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: EV/DNG (Qlaira, BAY86-5027)
Arm 2Active comparatorNot described
Receives: Drug: Encapsulated Microgynon + Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare SH T00658ID (Qlaira) to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 combined into a single endpoint

    Measured: Baseline to cycle 6

Secondary outcomes (9)

  1. Rescue medication consumption

    Measured: Baseline to cycle 6

  2. Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28

    Measured: Baseline to cycle 6

  3. Prevalence of individual hormone-related symptoms during cycle days 1 to 21

    Measured: Baseline to cycle 6

  4. Prevalence of individual hormone-related symptoms during hormone-free interval, i.e. cycle days 27+28 for EV/DNG capsules and cycle days 22 to 28 for the comparator

    Measured: Baseline, cycle 3 and cycle 6

  5. Change in the average of the 3 highest VAS values of the hormone withdrawal associated symptoms pelvic pain or headache during cycle days 22 to 28 from baseline to cycle 3

    Measured: Baseline to cycle 3

  6. Bleeding pattern and cycle control

    Measured: Throughout

  7. QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)

    Measured: Baseline, cycle 2 and cycle 5

  8. AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight

    Measured: Throughout

  9. General physical and gynecological examination

    Measured: Screening and Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
449 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00778609
Sponsor's protocol ID
91550
Other IDs
310787, 2008-003226-42, 2008
Status last verified
Jan 2016
First submitted
22 Oct 2008
Last updated
14 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Macias G, Merki-Feld GS, Parke S, Mellinger U, Serrani M. Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: results from the multicentre, randomised, double-blind, active-controlled HARMONY II study. J Obstet Gynaecol. 2013 Aug;33(6):591-6. doi: 10.3109/01443615.2013.800851.

    PubMed 23919857

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027) in people with Oral Contraceptive and Headache, run by Bayer at 63 sites in 9 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 4 inclusion and 1 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 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in France, Australia, Germany, Spain, United Kingdom and 4 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

To compare SH T00658ID (Qlaira) to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 combined into a single endpoint (time frame: Baseline to cycle 6). 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 NCT00778609, 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 14 Jan 2016.

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