Clinical trial NCT01638923: Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding
Official title: A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metrorrhagia
Keywords: Heavy Menstrual Bleeding
Efficacy
Safety
Oral contraceptive
Estradiol valerate
Dienogest
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-07-12
Enrollment: 339
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding


Eligibility criteria: Inclusion Criteria:

* Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception
* Willingness to use barrier contraception (e.g., condoms) from screening to study completion
* Willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion

Exclusion Criteria:

* Current diagnosis of organic uterine bleeding
* History of endometrial ablation, or dilatation and curettage within 2 months of Visit 1.
* Clinically significant pelvic findings (whether or not confirmed by transvaginal ultrasound \[TVU\]).
* Clinically significant abnormal results of breast examination (breast palpation).
* Positive pregnancy test at Visit 1
* Less than three months since delivery, abortion, or lactation before to start Visit 1
* Other contraceptive methods
* Any disease or condition that may worsen under hormonal treatment
* Smokers over the age of 35
* Body mass index \>32

Primary outcomes:
measure: Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days
timeFrame: 90 day baseline period and 90 days during treatment period
Secondary outcomes:
measure: Proportion of subjects with successful treatment
timeFrame: 90 days during treatment phase
measure: Percent change of MBL at baseline and 90 day period during treatment phase
timeFrame: Baseline and 90 days during treatment phase
measure: Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)
timeFrame: Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7
measure: Proportion of subjects with improvement in the investigator's global assessment scale on Day 84
timeFrame: Treatment day 84
measure: Proportion of subjects with improvement in the investigator's global assessment scale on Day 196
timeFrame: Treatment day 196
measure: Proportion of subjects with improvement in the subject's global assessment scale on Day 84
timeFrame: Treatment day 84
measure: Proportion of subjects with improvement in the subject's global assessment scale on Day 196
timeFrame: Treatment day 196
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Nanning
country: China
state: Guangxi
city: Shijiazhuang
country: China
state: Hebei
city: Wuhan
country: China
state: Hubei
city: Wuhan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Hengyang
country: China
state: Hunan
city: Dalian
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Xi'an
country: China
state: Shaanxi
city: Jinan
country: China
state: Shandong
city: Chengdu
country: China
state: Sichuan
city: Chengdu
country: China
state: Sichuan
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Changchun
country: China
city: Chongqing
country: China
city: Qingdao
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Tianjin
country: China
city: Manila
country: Philippines
city: Quezon City
country: Philippines
city: Irkutsk
country: Russian Federation
city: Ivanovo
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: