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

Primary Purpose

Oral Contraceptive, Headache, Pelvic Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EV/DNG (Qlaira, BAY86-5027)
Encapsulated Microgynon + Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Contraceptive focused on measuring Combined Oral Contraceptives, Pelvic Pain, Headache

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Women with any contraindication for oral contraceptive use

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rescue medication consumption
Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28
Prevalence of individual hormone-related symptoms during cycle days 1 to 21
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
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
Bleeding pattern and cycle control
QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)
AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight
General physical and gynecological examination

Full Information

First Posted
October 22, 2008
Last Updated
January 13, 2016
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00778609
Brief Title
Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 (Microgynon).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Contraceptive, Headache, Pelvic Pain
Keywords
Combined Oral Contraceptives, Pelvic Pain, Headache

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
449 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
EV/DNG (Qlaira, BAY86-5027)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Encapsulated Microgynon + Placebo
Intervention Description
Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Rescue medication consumption
Time Frame
Baseline to cycle 6
Title
Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28
Time Frame
Baseline to cycle 6
Title
Prevalence of individual hormone-related symptoms during cycle days 1 to 21
Time Frame
Baseline to cycle 6
Title
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
Time Frame
Baseline, cycle 3 and cycle 6
Title
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
Time Frame
Baseline to cycle 3
Title
Bleeding pattern and cycle control
Time Frame
Throughout
Title
QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)
Time Frame
Baseline, cycle 2 and cycle 5
Title
AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight
Time Frame
Throughout
Title
General physical and gynecological examination
Time Frame
Screening and Final Visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Women with any contraindication for oral contraceptive use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Ashfield
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
City
Caringbah
State/Province
New South Wales
ZIP/Postal Code
2229
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
Fortitude Valley
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
City
Kipparing
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5005
Country
Australia
City
Norwood
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3163
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
City
Helsinki
ZIP/Postal Code
00350
Country
Finland
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
City
Brignoles
ZIP/Postal Code
83170
Country
France
City
Maison Lafitte
ZIP/Postal Code
78600
Country
France
City
Nancy
ZIP/Postal Code
54042
Country
France
City
Nantes
ZIP/Postal Code
44000
Country
France
City
Nantes
ZIP/Postal Code
44093
Country
France
City
Olivet
ZIP/Postal Code
45160
Country
France
City
Paris
ZIP/Postal Code
75007
Country
France
City
Paris
ZIP/Postal Code
75015
Country
France
City
Paris
ZIP/Postal Code
75018
Country
France
City
Saint Germain En Laye
ZIP/Postal Code
78100
Country
France
City
Seclin
ZIP/Postal Code
59113
Country
France
City
Tarare
ZIP/Postal Code
69170
Country
France
City
Toulouse
ZIP/Postal Code
31000
Country
France
City
Rheinstetten
State/Province
Baden-Württemberg
ZIP/Postal Code
76287
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60322
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30459
Country
Germany
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45127
Country
Germany
City
Wuppertal
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42103
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39126
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
City
Hamburg
ZIP/Postal Code
22359
Country
Germany
City
Mexico
State/Province
México
ZIP/Postal Code
06700
Country
Mexico
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83100
Country
Mexico
City
Mexico, D.F.
ZIP/Postal Code
3100
Country
Mexico
City
México, D.F.
ZIP/Postal Code
07760
Country
Mexico
City
Benidorm
State/Province
Alicante
ZIP/Postal Code
03503
Country
Spain
City
Petrer
State/Province
Alicante
ZIP/Postal Code
03610
Country
Spain
City
Gijón
State/Province
Asturias
ZIP/Postal Code
33212
Country
Spain
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08013
Country
Spain
City
Madrid
ZIP/Postal Code
28001
Country
Spain
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Bern
ZIP/Postal Code
3013
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Cheadle
State/Province
Cheshire
ZIP/Postal Code
SK8 5LL
Country
United Kingdom
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
City
Weston-super-Mare
State/Province
North Somerset
ZIP/Postal Code
BS23 4BP
Country
United Kingdom
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG2 4PJ
Country
United Kingdom
City
Glasgow
State/Province
Stratchclyde
ZIP/Postal Code
G45 9AW
Country
United Kingdom
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23919857
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

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

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