Effect of Piroxicam on Ovulation

Single-center, Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Evaluate Whether a Single-dose of Either 20 mg Piroxicam, 40 mg Piroxicam or 80 mg Piroxicam Shows an Effect on Ovulation After the Onset of LH Surge Compared to Placebo in Healthy Young Women

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320709

Enrollment

Registered

2011-03-22

Start date

2011-03-31

Completion date

2012-05-31

Last updated

2015-07-10

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

Conditions

Contraception, Postcoital

Keywords

Emergency contraception, Contraception

Brief summary

In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone which triggers ovulation). Additionally blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition the concentration of piroxicam in blood will be determined in regular intervals. With regards to the tolerability of the study drug subjects will be asked regularly how they feel.

Interventions

DRUGPiroxicam ( BAYl1902)

Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)

DRUGPlacebo

Single dose of placebo (i.e., 4 placebo capsules)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Signed informed consent available before any study specific tests or procedures are performed * Healthy female subject * Age: 18 to 35 years (inclusive) at the first screening visit * Body mass index (BMI ): 18-30 kg/m² (inclusive) at the first screening visit * Confirmation of the subject's health insurance coverage prior to the first screening visit * Willingness to use non-hormonal methods of contraception during the study * Ability to understand and follow study-related instructions * Adequate venous access

Exclusion criteria

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal * Hypersensitivity to the active substance or skin reactions (irrespective of severity) to piroxicam, non-steroidal anti-inflammatory drugs or other medicinal products in the past * History or presence of inflammatory diseases of the gastrointestinal tract, gastrointestinal bleeding, ulcers or perforation * Regular intake of medication other than hormonal contraceptives * Clinically relevant findings in the gynecological examination including transvaginal ultrasound (TVU) * Clinically relevant findings in the physical examination, especially signs of bleeding diathesis or heart failure * Time point onset of LH surge in the pre-treatment cycle not determinable * Time point ovulation in the pre-treatment cycle not determinable * Lacking suitability for frequent TVU examinations * History or presence of suffering from hay fever

Design outcomes

Primary

Measure	Time frame
Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge	after 2 months

Secondary

Measure	Time frame
course of follicle sizes	after 2 months
course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)	after 2 months
Concentration-times courses of piroxicam	after 2 months

Countries

Germany

Outcome results

None listed

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