Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D

Single Center, Double-blind, Randomized Study to Compare the Effect of SH T 00186 D on Follicular Development in a 24-day Regimen Versus a 21-day Regimen in Healthy Female Volunteers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00673686

Enrollment

105

Registered

2008-05-07

Start date

2004-05-31

Completion date

2005-02-28

Last updated

2014-10-13

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

Conditions

Contraceptives, Oral

Keywords

Oral contraceptive, Ovulation, Missing pills, Intake compliance, Cycle control

Brief summary

In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on contraceptive robustness of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.

Interventions

DRUGYAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each

DRUGYasminelle (SH T 00186 D)

SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive) * No contraindications for combined oral contraceptive (COC) use * Follicular diameter of greater-equal than 15 mm on visit 6 (admission to treatment), or an observed ovulation during pretreatment cycle

Exclusion criteria

* Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) \> 30, * Known hypersensitivity to any of the study drug ingredients * Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study, or the interpretation of the results

Design outcomes

Primary

Measure	Time frame
Hoogland scores in cycles 2 and 3	Treatment cycles 2 and 3 (treatment weeks 5-12)

Secondary

Measure	Time frame
Follicle size	Treatment cycles 2 and 3 (treatment weeks 5-12
Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone	Treatment cycles 2 and 3 (treatment weeks 5-12
Endometrial thickness	Treatment cycles 2 and 3 (treatment weeks 5-12
Cervical mucus	Treatment cycles 2 and 3 (treatment weeks 5-12

Countries

Netherlands

Outcome results

None listed

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