A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles

A Double-blind, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Oral Estradiol / Drospirenone Regimens in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00631124

Enrollment

103

Registered

2008-03-07

Start date

2008-02-29

Completion date

2008-12-31

Last updated

2014-12-02

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

Conditions

Contraception

Keywords

Contraception

Brief summary

Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles

Interventions

DRUGBAY86-4891 (Estradiol / Drospirenone)

Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy female volunteers, * Age 18 - 35 years

Exclusion criteria

* Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease) * Regular intake of medication * Clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination) * Anovulatory pre-treatment cycle

Design outcomes

Primary

Measure	Time frame
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no	12 months

Secondary

Measure	Time frame
Assessment of ovarian activity in treatment cycles 2 and 3	12 months
Course of gonadotropins (FSH, LH)	12 months
Endometrial growth	12 months
Pharmacokinetics of estrogen and progestin in treatment cycle 3	12 months

Countries

Germany

Outcome results

None listed

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