Regulation of Cervical Mucus Secretion

Status Completed

Clinical Trial Summary

The purpose of this study is to help us determine how hormones impact the production of cervical mucus which is a fluid secreted by the opening of the uterus, also called the cervix. During a normal menstrual cycle, cervical mucus changes in response to two hormones that the ovaries make: estrogen and progesterone. Many of the birth control methods women use thicken mucus and make it less likely for sperm to enter the uterus. The goal of this study is to better understand the effects estrogen and progesterone have on the cervical mucus in the body. To do this, the investigators will be using a drug that suppresses natural hormone production for 3 months. Estrogen and progesterone will be artificially replaced to better understand their effects. The investigators will also be studying the effect of a common birth control pill that may work by thickening cervical mucus. Last, the investigators will study some of the cells in the cervix that produce mucus.

Clinical Trial Description

This proposed study is to evaluate the temporal changes in human cervical mucus in response to progesterone and progestins as an initial step toward clarifying these relationships. Our hypothesis is that direct effects of progesterone on the endocervix, independent of estrogen withdrawal, cause contraceptive changes to cervical mucus. To study this, a randomized, prospective, crossover study will be conducted by examining cervical mucus changes in a small cohort of women in whom investigators will suppress circulating hormonal levels by administering a GnRH antagonist. Investigators will then artificially replace Estrogen and Progesterone in order to differentiate their effects on clinical and laboratory measurements of mucus quality. The investigators will be looking closely at the immediate changes in mucus when .35 mg of norethindrone, a marketed drug is administered in this experimental setting. Cervical cell samples will also be collected at various time points and perform RT-PCR to determine whether genes for membrane bound progesterone receptor are expressed and regulated by Estrogen and Progesterone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02969590
Study type	Interventional
Source	Oregon Health and Science University
Contact
Status	Completed
Phase	Phase 4
Start date	March 29, 2015
Completion date	August 23, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02577601` - Impact of Combined Hormonal Contraceptives on UPA	Phase 4
Completed	`NCT03153644` - Improving Contraceptive Care for Women With Medical Conditions
Completed	`NCT04112095` - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use	Phase 3
Recruiting	`NCT05521646` - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative	N/A
Active, not recruiting	`NCT04291001` - Ovarian Function With ENG Implant and UPA Use	Early Phase 1
Completed	`NCT04568980` - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed	`NCT03438682` - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting	`NCT01948882` - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women	N/A
Enrolling by invitation	`NCT04997499` - Adolescent Subcutaneous (SQ) Injection Video Validation	N/A
Recruiting	`NCT03589040` - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant	Phase 2
Completed	`NCT04463680` - Rifampin and the Contraceptive Implant	Phase 4
Completed	`NCT03154125` - Sayana® Press Extension Study	Phase 3
Withdrawn	`NCT03725358` - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.	N/A
Completed	`NCT02957630` - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"	Phase 1/Phase 2
Completed	`NCT02456584` - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods	Phase 1
Completed	`NCT02718222` - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services	N/A
Recruiting	`NCT02121067` - LNG-IUS at 2 Weeks Postpartum	Phase 4
Terminated	`NCT02169869` - Immediate Postplacental IUD Insertion	N/A
Recruiting	`NCT02292056` - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions	N/A
Withdrawn	`NCT01930994` - Kenya Sino-implant (II) PK Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.