Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

Multicenter, Open-label, Randomized, Comparative Study to Evaluate Ovulation Inhibition With Two 4-phasic Oral Contraceptive Regimens Containing Estradiol Valerate and Dienogest Applied Daily for Three Cycles to 200 Healthy Female Volunteer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00805415

Enrollment

209

Registered

2008-12-09

Start date

2003-03-31

Completion date

2004-02-29

Last updated

2011-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovulation Inhibition

Keywords

Oral Contraceptive, Ovulation Inhibition

Brief summary

The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.

Interventions

DRUGEV/DNG (Qlaira, BAY86-5027, SH T00658K)

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg

DRUGEV/DNG (SH T00658L)

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women willing to use non-hormonal methods of contraception

Exclusion criteria

* Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease

Design outcomes

Primary

Measure	Time frame
Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)	Treatment cycles 2 and 3

Secondary

Measure	Time frame
Measurements of endometrial thickness	Treatment cycles 2 and 3
Visibility of cervical mucus	Treatment cycles 2 and 3
Ovarian activity (Hoogland score)	Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3
Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)	Treatment cycles 2 or 3
Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)	Treatment cycles 2 and 3
Compliance	Throughout whole study
Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signs	Various timepoint throughout the study
Measurements of follicle size	Treatment cycles 2 and 3

Countries

Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026